Remel Inc
Lenexa, KS, US
REMEL, INC. appears in FDA device records in Lenexa, KS. FDA records list 107 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 113 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Remel Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Thermo Fisherenforcement report, recall
510(k) clearance history
Showing 50 of 107FDA records hold 107 510(k) clearances for Remel Inc between 1984 and 2017. The busiest year on record is 1991, with 17. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 10 |
| 1988 | 5 |
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 17 |
| 1992 | 16 |
| 1993 | 9 |
| 1994 | 7 |
| 1996 | 9 |
| 1997 | 10 |
| 1998 | 1 |
| 2001 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162620 | Remel Spectra ESBL | JSO | Substantially Equivalent | |
| K131804 | REMEL XPECT FLU A&B | GNX | Substantially Equivalent | |
| K092407 | REMEL SPECTRA MRSA | JSO | Substantially Equivalent | |
| K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | MJE | Substantially Equivalent | |
| K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B | LLH | Substantially Equivalent | |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | MHI | Substantially Equivalent | |
| K031565 | XPECT INFLUENZA A/B | PSZ | Substantially Equivalent | |
| K013711 | BACTI-SWAB DRY | LIO | Substantially Equivalent | |
| K981391 | PAR-ONE | LIO | Substantially Equivalent | |
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | JSO | Substantially Equivalent | |
| K970832 | PYR SWAB | JTO | Substantially Equivalent | |
| K970834 | GRAM SWAB | JTO | Substantially Equivalent | |
| K970833 | INDOLE SWAB | JTO | Substantially Equivalent | |
| K970831 | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK | JTN | Substantially Equivalent | |
| K970830 | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK | JTN | Substantially Equivalent | |
| K965152 | A.C.T. II | JSM | Substantially Equivalent | |
| K965151 | A.C.T. III | JSM | Substantially Equivalent | |
| K965150 | A.C.T. IV | JSM | Substantially Equivalent | |
| K965149 | A.C.T. I | JSM | Substantially Equivalent | |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K961046 | 10B ARGININE BROTH | JSM | Substantially Equivalent | |
| K961819 | STREPTOMYCIN DISK (300MCG) | JTN | Substantially Equivalent | |
| K961818 | GENTAMICIN DISK (120MCG) | JTN | Substantially Equivalent | |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | JTZ | Substantially Equivalent | |
| K960095 | BACTIDROP CALCOFLUOR WHITE | JTS | Substantially Equivalent | |
| K960090 | CALCOFLUOR WHITE STAIN KIT | JTS | Substantially Equivalent | |
| K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K954986 | GC BASE W/ 1% GCHI | JTY | Substantially Equivalent | |
| K941444 | BHI AGAR WITH VANCOMYCIN | JSO | Substantially Equivalent | |
| K941443 | SYNERGY QUAD | JSO | Substantially Equivalent | |
| K935975 | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG | JTN | Substantially Equivalent | |
| K936021 | BACTICARD STREP | JTO | Substantially Equivalent | |
| K933457 | RIM E.COLI 0157:H7 LATEX TEST | GNA | Substantially Equivalent | |
| K935124 | BACTICARD CANDIDA | JXB | Substantially Equivalent | |
| K934986 | BACTICARD E. COLI | JTO | Substantially Equivalent | |
| K934100 | REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K933657 | REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K933514 | BACTICARD STREP | JTO | Substantially Equivalent | |
| K933118 | REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K931799 | REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K931383 | ZINC PVA | LIO | Substantially Equivalent | |
| K931289 | REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K931290 | REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K930878 | BACTIDROP(TM) MUCAP | JTO | Substantially Equivalent | |
| K925060 | REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K924846 | REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K923566 | NIZYME TEST KIT | JSX | Substantially Equivalent | |
| K924766 | REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K924765 | REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK | JTN | Substantially Equivalent | |
| K923700 | INDOXYL ACETATE DISK | JTO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1924669 | 1924669 | REMEL, INC. | 12076 Santa Fe Trail Dr, LENEXA, KS 66215 US | 2026 | and 64 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IDCAcridine Orange
- KFDAniline Blue
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQBAntigens, Cf (Including Cf Control), Reovirus 1-3
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- GNAAntisera, All Types, Escherichia Coli
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- KXGApplicator, Absorbent Tipped, Sterile
- JIOBlood, Occult, Colorimetric, In Urine
- ICLCarbol Fuchsin
- JSLCulture Media, Anaerobic Transport
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- KZICulture Media, Enriched
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSCCulture Media, General Nutrient Broth
- JSECulture Media, Multiple Biochemical Test
- JSMCulture Media, Non-Propagating Transport
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSNCulture Media, Propagating Transport
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JSFCulture Media, Single Biochemical Test
- LIBDevice, General Purpose, Microbiology, Diagnostic
- JTCDevice, Microtiter Diluting/Dispensing
- LIODevice, Specimen Collection
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- LDXFixative, Metallic Containing
- JFOFluorometric, Calcium
- IFPFormalin, Neutral Buffered
- IFQFormulations, Mercuric Chloride For Tissue
- HYFGiemsa Stain
- HYIIodine, Grams
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- JSWKit, Identification, Glucose Nonfermenter
- JSXKit, Identification, Neisseria Gonorrhoeae
- JXBKit, Identification, Yeast
- JTRKit, Quality Control For Culture Media
- JWXKit, Screening, Staphylococcus Aureus
- JWZKit, Screening, Trichomonas
- JXCKit, Screening, Yeast
- JWYManual Antimicrobial Susceptibility Test Systems
- JQXNephelometer, For Clinical Use
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- LJGQuality Control Slides
- LIEReagent/Device, Inoculum Calibration
- LLHReagents, Clostridium Difficile Toxin
- HZSSafranin
- IGBSolution, Formalin-Sodium Acetate
- JTSStains, Microbiologic
- JSKSupplement, Culture Media
- JTNSusceptibility Test Discs, Antimicrobial
- KTNSystem, Test, Infectious Mononucleosis
- JTWSystem, Transport, Aerobic
- JTXTransport Systems, Anaerobic
Recall records
Showing 25 of 113| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2623-2026 | GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Reduced or no recovery of some strains of Neisseria gonorrhoeae. | Class II | Open, Classified | |
| Z-1806-2026 | Yeastone Broth, 11ML, 10/BOX YY3462 | Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result. | Class II | Open, Classified | |
| Z-1474-2026 | Campy CVA Medium 100/PK, R01272 | Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. | Class II | Open, Classified | |
| Z-0585-2026 | 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 | Products may contain contamination, which may result in a darker or brown media color. | Class II | Open, Classified | |
| Z-2226-2025 | Blood/MacConkey Biplate 100/PK, Product Number R02049 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Open, Classified | |
| Z-2225-2025 | Blood/EMB, Levine 100/PK, Product Number R02041 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Open, Classified | |
| Z-2224-2025 | Strep Selective II Agar, Product Number R01859 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Open, Classified | |
| Z-2223-2025 | Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 | The products may contain surface and subsurface contamination of Listeria monocytogenes. | Class II | Open, Classified | |
| Z-1947-2025 | Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device | Product may have an off color affecting perfomance | Class II | Open, Classified | |
| Z-1201-2025 | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. | Class II | Open, Classified | |
| Z-1200-2025 | remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate. | Class II | Open, Classified | |
| Z-1395-2025 | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. | Class II | Open, Classified | |
| Z-0266-2025 | remel BactiDrop Acridine Orange, REF 21502, 50 per package. | A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results. | Class II | Open, Classified | |
| Z-2531-2023 | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples | Class II | Open, Classified | |
| Z-2038-2023 | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. | The test medium may not perform as intended. | Class II | Open, Classified | |
| Z-0335-2023 | Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0334-2023 | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0333-2023 | Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0332-2023 | Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0331-2023 | Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0330-2023 | Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0329-2023 | Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0328-2023 | Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0327-2023 | Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST | An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam. | Class I | Terminated | |
| Z-0722-2022 | Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format | There are lower than expected MICs for some gram negative species. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Remel Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain