Fisher Diagnostics
Middletown, VA, US
Fisher Diagnostics appears in FDA device records in Middletown, VA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 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 Fisher Diagnostics 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.
- Fisher Diagnostic, A Company of Fisher Scientific LLCrecall
- Fisher Diagnostics, A Company of Fisher Scientific LLCrecall
510(k) clearance history
FDA records hold 16 510(k) clearances for Fisher Diagnostics between 1983 and 2017. The busiest year on record is 1985, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 3 |
| 2001 | 1 |
| 2002 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls | PRI | Substantially Equivalent | |
| K070640 | ARCHITECT STAT TROPONIN-1; MYOGLOBIN | MMI | Substantially Equivalent | |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | JZO | Substantially Equivalent | |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | JZO | Substantially Equivalent | |
| K042924 | ARCHITECT STAT MYO IMMUNOASSAY | DDR | Substantially Equivalent | |
| K041192 | ARCHITECT STAT TROPONIN-I IMMUNOASSAY | MMI | Substantially Equivalent | |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | JHX | Substantially Equivalent | |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN | GKP | Substantially Equivalent | |
| K013397 | PACIFIC HEMOSTASIS REFERENCE EMULSION | JIX | Substantially Equivalent | |
| K010750 | PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 | GGN | Substantially Equivalent | |
| K850160 | FISHER DIAGNOSTICS LATEST-CRP TEST KIT | DCK | Substantially Equivalent | |
| K844346 | FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES | JHJ | Substantially Equivalent | |
| K844347 | FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT | JHJ | Substantially Equivalent | |
| K844047 | FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS | JIT | Substantially Equivalent | |
| K840921 | THERACHEM TDC THERAPEUTIC DRUG CONTROL | DIF | Substantially Equivalent | |
| K833514 | TOXI CHEM SERUM ALCOHOL CONTROL | DKC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1181121 | 1181121 | Fisher Diagnostics | 8365 VALLEY PIKE, MIDDLETOWN, VA 22645 US | 2026 | and 108 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- GFOActivated Partial Thromboplastin
- DKCAlcohol Control Materials
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- CJYAzo Dye, Calcium
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DLJCalibrators, Drug Specific
- DIHColorimetry, Cholinesterase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- GGCControl, Plasma, Abnormal
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- GIFDiluent, Blood Cell
- DIFDrug Mixture Control Materials
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLZEnzyme Immunoassay, Phenobarbital
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- GKPInstrument, Coagulation, Automated
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- GGKProducts, Red-Cell Lysing Products
- GJHStain, Reticulocyte
- DHRSystem, Test, Rheumatoid Factor
- GISTest, Fibrinogen
- GHMTest, Sickle Cell
- GJSTest, Time, Prothrombin
- DDGTransferrin, Antigen, Antiserum, Control
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1503-2025 | Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays. | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Class II | Open, Classified | |
| Z-1502-2025 | Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays. | The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label. | Class II | Open, Classified | |
| Z-2763-2017 | Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives. | Class II | Terminated | |
| Z-2762-2017 | Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine. | An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives. | Class II | Terminated | |
| Z-1519-2011 | Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays. | An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples. | Terminated | ||
| Z-1496-04 | Pacific Hemostasis brand SickleScreen Sickling Hemoglobin Screening Kit, Fisher Diagnostics catalog number 100250, containing reagents for 30 determinations. | Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives. | Terminated | ||
| Z-1336-04 | Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. | Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain