Fisher Diagnostics

Contract manufacturer · Middletown, VA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

1992Product codes first listed, by year (tallest: 48)2026

FDA registration: 1181121 (openFDA record; or search FDA's registration database)
FEI number: 1181121
Registered for: FDA registration year 2026
Establishment types: Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator: Thermo Fisher Scientific (FDA owner/operator no. 2517925)
Registered address: 8365 VALLEY PIKE, Middletown, VA 22645
Contract listings: 79 device listings, 79 product codes, first listed Dec 16, 1992
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
CDO	Acid, Uric, Uricase (U.V.)	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Class I	Clinical chemistry	Contract manufacturing	Dec 16, 1992
CEK	Biuret (Colorimetric), Total Protein	Class II	Clinical chemistry	Contract manufacturing	Dec 16, 1992
CEM	Electrode, Ion Specific, Potassium	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Class II	Clinical chemistry	Contract manufacturing	Dec 16, 1992
CFM	Bathophenanthroline, Colorimetry, Iron (Non-Heme)	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CGX	Alkaline Picrate, Colorimetry, Creatinine	Class II	Clinical chemistry	Contract manufacturing	Mar 15, 2016
CGZ	Electrode, Ion-Specific, Chloride	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Class II	Clinical chemistry	Contract manufacturing	Aug 28, 2015
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CIX	Bromcresol Green Dye-Binding, Albumin	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CJW	Bromcresol Purple Dye-Binding, Albumin	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CJY	Azo Dye, Calcium	Class II	Clinical chemistry	Contract manufacturing	Oct 20, 2015
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Class I	Clinical chemistry	Contract manufacturing	Dec 16, 1992
CKB	Acid Phosphatase, Naphthyl Phosphate	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
CZP	Iga, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
CZW	Complement C3, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DAD	Haptoglobin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DBI	Complement C4, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DDG	Transferrin, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DER	Alpha-1-Lipoprotein, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DEW	Igg, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DFT	Igm, Antigen, Antiserum, Control	Class II	Immunology	Contract manufacturing	Jan 30, 2013
DHR	System, Test, Rheumatoid Factor	Class II	Immunology	Contract manufacturing	Feb 1, 2013
DIP	Enzyme Immunoassay, Diphenylhydantoin	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
DLJ	Calibrators, Drug Specific	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
DLZ	Enzyme Immunoassay, Phenobarbital	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
GGK	Products, Red-Cell Lysing Products	Class I	Hematology	Contract manufacturing	Jan 30, 2013
GIF	Diluent, Blood Cell	Class I	Hematology	Contract manufacturing	Feb 24, 2005
GJH	Stain, Reticulocyte	Class I	Hematology	Contract manufacturing	Jan 28, 1997
GKL	Counter, Cell, Automated (Particle Counter)	Class II	Hematology	Contract manufacturing	Jan 30, 2013
GKZ	Counter, Differential Cell	Class II	Hematology	Contract manufacturing	Jan 30, 2013
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Class II	Radiology	Contract manufacturing	Jan 30, 2013
JCB	Detergent	Class I	Pathology	Contract manufacturing	Jan 30, 2013
JFP	Electrode, Ion Specific, Calcium	Class II	Clinical chemistry	Contract manufacturing	Nov 10, 2017
JGJ	Photometric Method, Magnesium	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JGQ	Turbidimetric, Total Protein	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JGS	Electrode, Ion Specific, Sodium	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JIH	Flame Photometry, Lithium	Class II	Clinical toxicology	Contract manufacturing	Nov 10, 2017
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Class II	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JIO	Blood, Occult, Colorimetric, In Urine	Class II	Hematology	Contract manufacturing	Jan 6, 2015
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Nov 28, 2016
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JIS	Calibrator, Primary	Class II	Clinical chemistry	Contract manufacturing	May 15, 2013
JIT	Calibrator, Secondary	Class II	Clinical chemistry	Contract manufacturing	May 17, 2006
JIX	Calibrator, Multi-Analyte Mixture	Class II	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Class I	Clinical chemistry	Contract manufacturing	May 17, 2006
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Class I	Clinical chemistry	Contract manufacturing	Jan 9, 2008
JRE	Refractometer For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
JZJ	Prealbumin, Antigen, Antiserum, Control	Class I	Immunology	Contract manufacturing	Jan 30, 2013
JZO	System, Test, Thyroid Autoantibody	Class II	Immunology	Contract manufacturing	May 17, 2006
KHQ	Radioassay, Triiodothyronine Uptake	Class II	Clinical chemistry	Contract manufacturing	May 21, 2007
KLS	Enzyme Immunoassay, Theophylline	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
KLT	Enzyme Immunoassay, Carbamazepine	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
KNK	Acid, Uric, Uricase (Colorimetric)	Class I	Clinical chemistry	Contract manufacturing	Jan 30, 2013
KQO	Automated Urinalysis System	Class I	Clinical chemistry	Contract manufacturing	Jan 6, 2015
LCP	Assay, Glycosylated Hemoglobin	Class II	Hematology	Contract manufacturing	Jan 30, 2013
LFR	Glucose Dehydrogenase, Glucose	Class II	Clinical chemistry	Contract manufacturing	Sep 13, 2013
LJX	Test, Urine Leukocyte	Class I	Hematology	Contract manufacturing	Jan 6, 2015
MRV	Drink, Glucose Tolerance	Class II	Clinical chemistry	Contract manufacturing	Feb 11, 2008
MZA	Test, Equipment, Automated Bloodborne Pathogen	Not classified	Immunology	Contract manufacturing	Feb 1, 2013
NBW	System, Test, Blood Glucose, Over The Counter	Class II	Clinical chemistry	Contract manufacturing	Sep 13, 2013
NDW	Assay, Porphyrin, Spectrophotometry, Lithium	Class II	Clinical toxicology	Contract manufacturing	Jan 30, 2013
PPM	General Purpose Reagent	Class I	Pathology	Contract manufacturing	Feb 24, 2005
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Class II	Microbiology	Contract manufacturing	Mar 22, 2023

Fisher Diagnostics

Devices listed as contract work

Other contract facilities of Thermo Fisher Scientific