FDA Registration Active 🇺🇸 United States

Fisher Diagnostics

Reg #: 1181121 · FEI: 1181121 · Expires 2026
Products
118
Proprietary Names
378
Establishment Types
5
Classifications
118

Registration Details

Registration Name
Fisher Diagnostics
Registration Number
1181121
FEI Number
1181121
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
8365 VALLEY PIKE
City
MIDDLETOWN
State
VA
ZIP
22645
Country
US

Regulatory Submissions

510(k) Number
K860715

Owner / Operator

Firm Name
Thermo Fisher Scientific
Operator Number
2517925
Address
168 Third Avenue, --
City
Waltham
State
MA
Postal Code
02451
Country
US

Products

Device Name Product Code
Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
Calibrator, Primary JIS
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes CJE
Plasma, Coagulation Control GGN
Calibrator, Secondary JIT
Calibrator, Multi-Analyte Mixture JIX
Prealbumin, Antigen, Antiserum, Control JZJ
Alkaline Picrate, Colorimetry, Creatinine CGX
Colorimetric Method, Triglycerides JGY
Enzymatic Esterase--Oxidase, Cholesterol CHH
Catalytic Methods, Amylase JFJ
Diazo Colorimetry, Bilirubin CIG
Biuret (Colorimetric), Total Protein CEK
Ferrozine (Colorimetric) Iron Binding Capacity JMO
Nadh Oxidation/Nad Reduction, Alt/Sgpt CKA
Nadh Oxidation/Nad Reduction, Ast/Sgot CIT
Enzymatic, Carbon-Dioxide KHS
Photometric Method, Iron (Non-Heme) JIY
Urease And Glutamic Dehydrogenase, Urea Nitrogen CDQ
Acid, Uric, Uricase (Colorimetric) KNK
Ph Buffer JCC
Control, Plasma, Abnormal GGC
Myoglobin, Antigen, Antiserum, Control DDR
Instrument, Coagulation KQG
Colorimetric Method, Gamma-Glutamyl Transpeptidase JPZ
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides CDT
U.V. Spectrometry, Theophylline LCY
System, Fibrinogen Determination KQJ
Iga, Antigen, Antiserum, Control CZP
System, Test, Rheumatoid Factor DHR
Multi-Analyte Controls, All Kinds (Assayed) JJY
Colorimetry, Cholinesterase DIH
Filters, Cell Collection, Tissue Processing KET
System, Test, Thyroid Autoantibody JZO
Drink, Glucose Tolerance MRV
Acid Phosphatase, Naphthyl Phosphate CKB
Diluent, Blood Cell GIF
Photometric Method, Magnesium JGJ
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
Electrode, Ion Specific, Sodium JGS
Electrode, Ion Specific, Potassium CEM
Electrode, Ion-Specific, Chloride CGZ
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase CFJ
Assay, Glycosylated Hemoglobin LCP
Solution, Isotonic JCE
Fibrin Split Products GHH
Cresolphthalein Complexone, Calcium CIC
Test System, Antineutrophil Cytoplasmic Antibodies (Anca) MOB
Bromcresol Purple Dye-Binding, Albumin CJW
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
Enzymatic Method, Creatinine JFY
Acid, Uric, Uricase (U.V.) CDO
Enzyme Immunoassay, Theophylline KLS
Calibrators, Drug Specific DLJ
Electrode, Ion Specific, Calcium JFP
Flame Photometry, Lithium JIH
Alpha-1-Lipoprotein, Antigen, Antiserum, Control DER
Mercuric Thiocyanate, Colorimetry, Chloride CHJ
Test, Sickle Cell GHM
Bromcresol Green Dye-Binding, Albumin CIX
Complement C4, Antigen, Antiserum, Control DBI
Test, Fibrinogen GIS
Turbidimetric, Total Protein JGQ
Hexokinase, Glucose CFR
Acid, Lactic, Enzymatic Method KHP
Plasma, Coagulation Factor Deficient GJT
Immunoassay Method, Troponin Subunit MMI
Automated Urinalysis System KQO
Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
Test, Urine Leukocyte LJX
Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
Refractometer For Clinical Use JRE
Blood, Occult, Colorimetric, In Urine JIO
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
Glucose Dehydrogenase, Glucose LFR
Counter, Differential Cell GKZ
Phosphomolybdate (Colorimetric), Inorganic Phosphorus CEO
Detergent JCB
Fluorometric Method, Cpk Or Isoenzymes JHX
Products, Red-Cell Lysing Products GGK
Stain, Reticulocyte GJH
Bathophenanthroline, Colorimetry, Iron (Non-Heme) CFM
Test, Equipment, Automated Bloodborne Pathogen MZA
Counter, Cell, Automated (Particle Counter) GKL
General Purpose Reagent PPM
Transferrin, Antigen, Antiserum, Control DDG
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes CGS
Instrument, Coagulation, Automated GKP
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph CHL
System, Applicator, Radionuclide, Remote-Controlled JAQ
Diethyldithiocarbamate (Colorimetric), Copper JKZ
Azo Dye, Calcium CJY
Enzymatic Method, Ammonia JIF
Test, Time, Prothrombin GJS
Activated Partial Thromboplastin GFO
Igg, Antigen, Antiserum, Control DEW
System, Test, Blood Glucose, Over The Counter NBW
Radioassay, Triiodothyronine Uptake KHQ
Assay, Porphyrin, Spectrophotometry, Lithium NDW
Enzyme Immunoassay, Phenobarbital DLZ
Enzyme Immunoassay, Carbamazepine KLT
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens PMT
Procalcitonin Assay PRI
Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission PTF
Kinetic Method, Gamma-Glutamyl Transpeptidase JQB
Complement C3, Antigen, Antiserum, Control CZW
Plasma, Control, Normal GIZ
Haptoglobin, Antigen, Antiserum, Control DAD
Igm, Antigen, Antiserum, Control DFT
Enzyme Immunoassay, Diphenylhydantoin DIP
Fluorometric, Cortisol JFT
Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC

Proprietary Names

Microalbumin Alinity c Microalbumin Calibrators Alinity c Microalbumin Reagent Kit Alinity c Microalbumin Controls AxSYM Probe Cleaning Solution Alkaline Phosphatase (TRIS) INR Controls INR Control Plasmas Glucose Standard (200mg/dL) Calcium Standard (10mg/dL) Phosphorus Standard (5.5mg/dL) Carbon Dioxide Standard (25mMol/L) Creatinine Standard (5mg/dL) Chloride Standard (100mm) Bicarbonate Standard, 25mEq/L Magnesium Standard (3.65mg/dL) Prealbumin Creatinine Infinity Creatinine Buffer pH XXX Phosphate-Buffered Saline pH 7.4 pH Control Standards Coagulation Control 3 Coagulation Control Level 3 Thermo Scientific dTIBC Calibrator Total Protein Reagent Alinity c Alkaline Phosphatase Reagent Kit Abbott Clinical Chemistry Alkaline Phosphatase Thromboscreen 200, Instrument GGT (Liquid) Reagent 1 Alinity c Gamma-Glutamyl Transferase Reagent Kit Gamma-Glutamyl Transferase Abbott Clinical Chemistry GGT Abbott Clinical Chemistry Triglycerides Theophylline Standard Alinity c Cholesterol Reagent Kit Abbott Clinical Chemistry Cholesterol Thrombin Time Reagent Activated Alanine Aminotransferase Alinity c Activated Alanine Aminotransferase Reagent Kit Alinity c Immunoglobulin A Reagent Kit HDL Low Control HDL High Control HDL Medium Control Cholinesterase Kit Roche Cell CollectionMedium 945 ML Kit Dispenser for 945 ML RCCM Bottle Kit Roche Cell Collection Medium 20 ML Reference Emulsion Fluid Alinity c Prealbumin Reagent Kit Kontact Reagent Kontact APTT Reagent Olympus Alkaline Phosphatase Iron Standard ARCHITECT ANTI-TPO Immunoassay Reagents Alinity i Anti-TPO Reagent Kit ARCHITECT Anti-TPO Controls ARCHITECT Anti-TPO Calibrators Glucocrush Fruit Punch (50, 75, 100) Glucocrush Orange (50, 75, 100) Glucocrush Lemon-Lime (50, 75, 100) Acid Phosphatase Liquid Stabilizer Acid Phosphatase AUTO CELLINE ISOTON DILUTANTS 1.3% SALINE CS-555 Nerl Blood Bank Saline (20L) Blood Bank Saline (10L) ISOTON DILUTANT Alinity h-series Diluent Infinity ACE Controls Alinity c ICT Sample Diluent Alinity c Activated Aspartate Aminotransferase Reagent Kit Activated Aspartate Aminotransferase Iron / UIBC Calibrators Alinity i Anti-Tg Calibrators Alinity i Anti-TPO Calibrators Alinity i Cortisol Calibrators Alinity i T-Uptake Calibrators Alinity i BRAHMS PCT Calibrators Lactate Dehydrogenase Blood Bank Saline Nerl Blood Bank Saline D-Dimer Latex Reagent D-Dimer Assay Kit Calcium Architect MPO Reagent Kit Alinity c Albumin BCP Reagent Kit Abbott Clinical Chemistry Albumin BCP DCA/Microalbumin Creatine Control Alinity c Triglyceride Reagent Kit Triglyceride Enzymatic Creatinine Reagent Lipid Controls CEM - ELECTRODE, ION SPECIFIC, POTASSIUM JGS - ELECTRODE, ION SPECIFIC, SODIUM JFP - ELECTRODE, ION SPECIFIC, CALCIUM Alinity c Carbon Dioxide Calibrator Bilirubin Calibrator Multiconstituent Calibrator Alinity c Urine/CSF Protein Calibrator Kit Alinity c Iron Calibrator Kit Alinity i Anti-TPO Controls Carbon Dioxide Calibrator Chloride Sicklescreen Assay Kits Sicklescreen Control Set Alinity c Albumin BCG Reagent Kit Cardiac Enzyme Control Fibrinogen Assay Kit Fibrinogen Reference Plasma Normal Fibrinogen Reference Plasma Imidazole Buffered Saline IBS Diluting Fluid Bovine Thrombin Barbital Buffered Saline Urine/CSF Protein Infinity Glucose Hexokinase Glucose Hexokinase Ammonia Standard Set Infinity BUN/Urea 2 x 125mL Abnormal Thrombin Time Control Low Fibrinogen Control High Fibrinogen Control Alinity c Lactic Acid Reagent Kit Lactate Liquid Lactic Acid Factor VIII Deficient Plasma, immun Architect Troponin-I Reagent Kit Architect Troponin-I Calibrator Kit Magnesium Alinity c Magnesium Reagent Kit Magnesium Arsenazo Normal Control Abnormal Control Clinitek Novus Rinse Additive Kit Clinitek Novus Calibrator Kit DiStat D-Dimer Assay Kit DiStat D-Dimer Control Kit Infinity Amylase Infinity Glucose Oxidase Glucose Oxidase DST Glucose Oxidase Glucose Oxidase LSP Infinity ACE Calibrator ACE CLINICAL CHEMISTRY SYSTEM ACE System Diluent Iron, Liquid Chromogen Reagent Calcium CPC Cell-DYN Emerald Cleaner Alinity c ICT Serum Calibrator Kit Alinity c Bilirubin Calibrator Kit Alinity c Multiconstituent Calibrator Kit Alinity c Carbon Dioxide Calibrator Kit Atellica CH Chemistry Calibrator Urine/CSF Protein Calibrator Aliniity c Iron Calibrator Kit Carbon Dioxide Calibrator (Architect) Multiconstituent Calibrator (Architect) ICT Serum Calibrator Kit Bilirubin Calibrator (Architect) Atellica CH A-LYTE IMT Dilution Check ARCHITECT STAT CK-MB I ARCHITECT STAT CK-MB Alinity c Urine/CSF Protein Reagent Kit AST (GOT) AST (DST) Infinity AST (GOT) RETICULOCYTE Reticulocyte Stain ARCHITECT STAT Myoglobin Controls ARCHITECT STAT CK-MB Controls Thromboscreen 400C Instrument Architect Rubella Control Kit Architect MPO Control Kit Alinity i T-Uptake Controls ARCHITECT B.R.A.H.M.S PCT Controls Calcium Arsenazo III Alinity c Total Protein Reagent Kit Total Protein Reagent Kit ARCHITECT BRAHMS PCT Calibrators Alinity c Urea Nitrogen Reagent Kit Multiple Accessories 95% Dehydrant Isopropanol R40132 Ethanol (95%) 70% Dehydrant R40106 TB Decolorizer (Acid Alcohol) 3% R2470110 Ethanol (70%) Methanol Flex 95 Cell Wash Solution I/NaOH-D 60% Dehydrant CleanCell M 2x2L, Para-Release Spray Isopropyl Alcohol Flex 100 100% Dehydrant R40206 TB Decolorizer (3%) R40134 Acid Ethanol (90%), Methyl Alcohol Flex 80 Acetone Base Mold Release Syntri Safeguard, Flex 100 Fast Flex Kit 1 Ethyl Alcohol 80% Dehydrant Cell Wash Solution I/NaOH-D 2x1, 8L Syntri Safeguard, Isopropyl Alcohol Fast Flex Kit 2 Reagent Alcohol Syntri Safeguard, Dehydrant 100% Clean Cell M 2x2L HE600 Cleaning Kit Alinity c Transferrin Reagent Kit Abbott Clinical Chemistry Transferrin Alinity c Creatinine Reagent Kit Olympus CK-NAC Alinity c Lactate Dehydrogenase Reagent Kit Fibrinogen Reagent with Kaolin Alinity c Phosphorus Reagent Kit Phosphorus Buffer 6.838 Wash G/L Zero Reagent Cal G/L Reagent Cleaning Solution 1 and Cleaning Solution 2 (C1/C2) Buffer 7.382 (7.3/CO-ox Zero Buffer) Infinity Uric Acid Uric Acid Glycine Buffered Saline FDP Sample Collection Tubes FDP Positive and Negative Control S FDP Assay Kit FDP Latex Reagent Clinitek Atlas Rinse Additive Clinitek Atlas Calibration Kit Clinitek Atlas Calibrator #4 (Clarity) Alkaline Phosphatase IFCC Alkaline Phosphatase PNPP Alkaline Phosphatase (AMP) Alkaline Phosphatase (AMP) Buffer ALP Copper 2-part Liquid ICT Reference Solution ICT Serum Calibrator Clinical Chemistry Alkaline Wash Clinical Chemistry Acid Wash Olympus Albumin CALCIUM Alinity c Calcium Reagent Kit Coagulation Control Level 2 Coagulation Control 2 Calibrator Set, High / Low DataCal Calibrator Reference Serum Infinity Ammonia Liquid Stable Reagent Thromboplastin-DS Reagent APTT-XL Reagent Calcium Chloride, 020M Calcium Chloride, 025M APTT-LS Reagent Albumin Hitachi Albumin Albumin BCP ARCHITECT Acid Wash ARCHITECT Alkaline Wash Alinity c Immunoglobulin G Reagent Kit Contour High Control Bayer Contour TS Countour Normal Control Contour Low Control Contour Normal Bulk, Contour Normal Single Control 125I T3 UPTAKE RADIOASSAY KIT ARCHITECT T-Uptake DRI T-Uptake (EIA Assay) Alinity i T-Uptake Reagent Kit DRI T-Uptake Calibrator Kit CEDIA T-Uptake Assay Microprotein Microprotein Standard ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37, 6P22-25, 6P22-35) Alinity i BRAHMS PCT Reagent Kit (LN 01R1821) ARCHITECT BRAHMS PCT Controls (LN 6P22-10) ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01) Alinity c Uric Acid Reagent Kit AcroMetrix Negative Control AcroMetrix HBV High Control AcroMetrix HIV-1 Low Control Acrometrix EV Low Control Acrometrix BB NAT HBV Positive Control AcroMetrix HCV High Control Alinity i Anti-Tg Controls AcroMetrix HIV-1 High Control AcroMetrix HIV-1 Mid Control Alinity i BRAHMS PCT Controls AcroMetrix HBV Low Control AcroMetrix BKV Low Control AcroMetrix HCV Mid Control MAS PTH Control AcroMetrix HCV Low Control AcroMetrix HBV Mid Control AcroMetrix BKV High Control Alinity c Cannabinoids Control 2 Kit MAS Diabetes Control Acrometrix EBV High Plasma Control MAS Bilirubin Control Acrometrix EV Negative Control DRI THC Urine Controls Acrometrix EBV Low Plasma Control MAS CardioImmune UL Alinity c Cannabinoids Control 1 Kit MAS SARS-CoV-2 IgG Positive Control MAS SARS-CoV-2 Negative Control MAS Diabetes Max Control Alinity Phosphorus Reagent Kit Olympus GGT GGT, Soluble Substrate GAMMA GT - GLUPA C GAMMA GT - SS Albumin Standard (4g/dL) Total Protein Standard (8g/dL) LDH-L LDH-P U.C.R.P. A.C.R.P. Contour Next Level 1 Contour Next Level 2 Alinity c Aspartate Aminotransferase Reagent Kit Aspartate Aminotransferase FisherBrand Sun-Dex (50,75,100) FisherBrand Fruit Punch (50,75,100) Trutol GTTB Fruit Punch (50,75,100) FisherBrand Limeondex (50,75,100) Trutol GTTB Lemon-Lime (50,75,100) Trutol GTTB Orange (50,75,100) GGT Enzyme Reagent UIBC Reagent Ferene Method Iron / UIBC UIBC Saturating Standard UIBC FerroZine Method Coagulation Control Level 1 Coagulation Control Plasma Level 1 Coagulation Controls Lithium Bulk Liquid Lithium Standard Infinity Lithium, Beckman SYNCHRON Olympus Lithium Infinity Lithium Reagent for Olympus® Analyzers Infinity Lithium (Li) Reagent for Beckman Coulter SYNCHRON Systems Infinity Lithium Standard Infinity Lithium Liquid Stable Reagent Infinity Lithium Infinity Lithium Liquid Reagent Direct Bilirubin Alinity c-series Acid Wash Alinity c-series Acid Probe Wash Alinity c-series ICT Reference Solution Alinity c-series Alkaline Wash High Low HIGH ARCHITECT T-UPTAKE CONTROLS ,LOW ARCHITECT T-UPTAKE CALIBRATORS Infinity AST (GPT) Infinity ALT (GPT) ARCHITECT Anti-TG Controls ARCHITECT Anti-TG Reagents Alinity i Anti-Tg Reagent Kit ARCHITECT ANTI-TG REAGENT ARCHITECT Anti-TG Calibrators ARCHITECT CORTISOL ASSAY Alinity i Cortisol Reagent Kit Amylase EPS-G7 Amylase Amylase LSP TRIGLYCERIDE,INFINITY,2X125 ML Cholesterol

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device