Chembio Diagnostic Systems, Inc.
Medford, NY, US
CHEMBIO DIAGNOSTIC SYSTEMS, INC. appears in FDA device records in Medford, NY. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Chembio Diagnostic Systems, 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.
- Chembio Diagnostic System Increcall
- Chembio Diagnostics, Incenforcement report, recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Chembio Diagnostic Systems, Inc. between 1992 and 2020. The busiest year on record is 2001, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1996 | 1 |
| 1999 | 1 |
| 2001 | 3 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200506 | DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader | QFO | Substantially Equivalent | |
| K011551 | SURE CHECK PREGNANCY TEST | LCX | Substantially Equivalent | |
| K011550 | HCG STAT PAK ULTRA-FAST | JHI | Substantially Equivalent | |
| K010244 | SURE CHECK OVULATION PREDICTOR | CEP | Substantially Equivalent | |
| K981913 | PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY | LSR | Substantially Equivalent | |
| K961965 | SURE CHECK PREGNANCY TEST | LCX | Substantially Equivalent | |
| K923925 | HCG STAT-PAK | JHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2431980 | 2431980 | CHEMBIO DIAGNOSTIC SYSTEMS, INC. | 3661 HORSEBLOCK RD., MEDFORD, NY 11763 US | 2026 | and 8 more, listed in full below |
| 3026565854 | 3026565854 | Chembio Diagnostic Systems | 1560 Fifth Avenue, Bay Shore, NY 11706 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QYDAdalimumab Assay
- GMQAntigens, Nontreponemal, All
- QCHAssayed Quality Control Material For Clinical Microbiology Assays
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- QKPCoronavirus Antigen Detection Test System.
- OSUDengue Serological Reagents
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi
- QXTInfliximab Test System
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- MWBKit, Test, Saliva, Hiv-1&2
- CEPRadioimmunoassay, Luteinizing Hormone
- LSRReagent, Borrelia Serological Reagent
- QKOReagent, Coronavirus Serological
- POGReagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
- MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- MZFTest, Hiv Detection
- NWYTest, Qualitative, Detection Of Dengue Igm And Igg Antibodies
- JHIVisual, Pregnancy Hcg, Prescription Use
- QFOZika Virus Serological Reagents
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2809-2020 | Chembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1070-0 | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Terminated | |
| Z-2808-2020 | Chembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 70-1069-0 | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Terminated | |
| Z-2807-2020 | Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium heparin or EDTA. Model Number: 65-9569-0 | FDA revocation of the Emergency Use Authorization due to performance issues | Class II | Terminated | |
| Z-0470-06 | Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. --- manufactured by: CHEMBIO DIAGNOSTIC SYSTEMS, INC., MEDFORD, NY 11763 --- Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A/A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml. | Firm received one report of a false negative with the positive control. Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations. | Terminated | ||
| Z-0277-05 | OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A. | Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives. | Terminated | ||
| Z-0276-05 | OTC Pregnancy Tests. Name: Sure Check hCG Midstream Pregnancy Test --- Description: the Sure Check hCG Midstream Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic ''wand'' with an absorbent wick at one end. The device is packaged in a foil pouch with desiccant. Catalog numbers are solely used for ordering by the different distributors. This OTC product is shipped as either bulk packaged product or as private labeled material labeled as follows: (1) SURE CHECK™ ONE STEP Pregnancy Test --- 1 TEST; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00110 3; Catalog # PT110SURE/12 (ordered by Dean Distribution, Fred's DC Memphis, Health Enterprises, Healthcare Products, Mason Distribution, Par-Med). (2) SURE CHECK™ ONE STEP Pregnancy Test --- 2 TESTS; MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC. MEDFORD, NY 11763 MADE IN USA; UPC 6 07158 00112 7; Catalog # PT112/24 (Fred's DC Memphis). (3) exact™ pregnancy test --- Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 66207 3; Catalog # PT110-N4 (Neuco). (4) exact™ pregnancy test --- 2 tests; Product of U.S.A./Produit des E-U. Prepared for/Prepare pour LOBLAWS INC. Montreal H4N 3L4, Toronto M4T 2S8, Calgary T2E 7S9, Canada By/Par Chembio Diagnostics Systems, Medford, New York 11763 Imported by/Import par Le Group Neuco Image Inc., Montreal, Quebec H2P 2T4 Canada; UPC 0 60383 68179; Catalog # PT112-N4 (Neuco). (5) OUR BEST NOTRE MEILLEUR ONE STEP PREGNANCY TEST (TEST DE GROSSESSE EN UNE ETAPE) --- 1 TEST --- PRODUCT OF U.S.A./PRODUIT DES E.-U. IMPORTED FOR/IMPORTE POUR: SOBEYS MISSISSAUGA, ON L4V 1W2. Manufactured by/Fabriqu par: CHEMBIO DIAGNOSTIC SYSTEMS, INC.; UPC 0 61925 57608; Catalog # PT110-N7 (Neuco). (6) BODY BASICS™ Pregnancy Test (Test de grossesse) --- 1 Test --- PRODUCT OF U.S.A./PRODUIT DES E.-U.A. MANUFACTURED BY/FABRIQUE PAR: CHEMBIO DIAGNOSTIC SYSTEMS, INC. IMPORTED FOR/IMPORTE POUR: THE GREAT ATLANTIC & PACIFIC COMPANY OF CANADA LTD. TORONTO, CANADA M5W1A6; UPC 0 57627 71110 9; Catalog # PT110-N6/12 (Neuco) (7) Option+ TEST DE GROSSESSE UNE ETAPE/ONE STEP PREGNANCY TEST --- Produit des E.U/Product of U.S.A. Fabrique pour/Manufactured for: UNIPRIX Inc. Montreal H1S 3G7; UPC 7 71290 05402 7; Catalog # PT110-N2 (Neuco). (8) True-Test™ Pregnancy Test Kit (Examen del Embarazo) One Step Testing --- 1 Test --- Distributed By: Ultras Pharmaceuticals, Inc. P.O. Box 370669 Las Vegas, NV 89137 U.S.A.; UPC 0 61406 37505 5; Catalog # PT110-R1 (Ultras). (9) Shaw's ONE-STEP Pregnancy Test ---1 TEST --- DISTRIBUTED BY SHAW'S SUPERMARKETS, INC. E. BRIDGEWATER, MA 02333, Made in USA; UPC 0 45674 65589 7; Catalog # PT110-S1 (Millbrook Distribution). (10) Harris Teeter Pregnancy Test Kits One Step Easy to use Pregnancy Test Kit --- Two Home Test Kits --- PROUDLY DISTRIBUTED BY: HARRIS TEETER MATTHEWS, NC 28105; UPC 0 72036 72061 0; Catalog # PT112-R2 (Harris Teeter). Bulk packaged product is assigned Catalog # PT110, with varying quantities (ordered by Savyon Diagnostics & Pruebas Moderna del Istmo). --- 510(k) K961965. | Poor sealing of pouches and degradation of products. Firm received an e-mail from a distributor of an increase in complaints. In response to the complaints, the distributor conducted its own functional testing and noticed a degradation in performance of the two lots. Chembio's investigation revealed invalid results (no control lines) and some false negatives. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain