Diamond Diagnostics Inc.

Reg #: 3006198300 · FEI: 3006198300 · Expires 2026

View on FDA

Products

241

Proprietary Names

Establishment Types

Classifications

241

Registration Details

Registration Name: Diamond Diagnostics Inc.
Registration Number: 3006198300
FEI Number: 3006198300
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 6 Oradna Street
City: Budapest
Country: HU

Regulatory Submissions

510(k) Number: K110520

Owner / Operator

Firm Name: Diamond Diagnostics Inc.
Operator Number: 10028706
Address: 333 Fiske St
City: Holliston
State: MA
Postal Code: 01746
Country: US
Correspondent: Kathy Fisher

US Agent

Business Name: DIAMOND DIAGNOSTICS INC.
Contact Name: Kathy Fisher
Address: 333 Fiske St
City: Holliston
State: MA
ZIP: 01746
Country: US
Email: [email protected]
Phone: 508 4290450 ext. 358

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2014-07-17
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2014-07-17
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2014-07-17
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2014-07-17
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2014-07-17
Assay, Carboxyhemoglobin	GHS	Class 2	Hematology	No	2020-09-01
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2020-09-01
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2020-09-01
Calibrator, Multi-Analyte Mixture	JIX	Class 2	Clinical Chemistry	No	2020-09-01
System, Hemoglobin, Automated	GKR	Class 2	Hematology	No	2020-09-01
Device, Hematocrit Measuring	JPI	Class 2	Hematology	No	2020-09-01
Oximeter To Measure Hemoglobin	GLY	Class 2	Hematology	No	2020-09-01
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2020-09-01
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	Class 2	Clinical Chemistry	No	2020-09-01
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2025-09-30
Bilirubin (Total And Unbound) In The Neonate Test System	MQM	Class 1	Clinical Chemistry	No	2025-09-30
Instrument, Hematocrit, Automated	GKF	Class 2	Hematology	No	2025-09-30
Calibrator, Primary	JIS	Class 2	Clinical Chemistry	No	2013-07-12
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2013-07-12
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2011-11-11
Counter, Differential Cell	GKZ	Class 2	Hematology	No	2011-11-11
Test, Equipment, Automated Bloodborne Pathogen	MZA	Class N	Unknown	No	2025-04-28
Analyzer, Chemistry, Micro, For Clinical Use	JJF	Class 1	Clinical Chemistry	No	2011-11-10
Instrument, Coagulation, Automated	GKP	Class 2	Hematology	No	2018-03-06
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2009-02-26
Counter, Cell, Automated (Particle Counter)	GKL	Class 2	Hematology	No	2011-11-10
Culture Media, Non-Propagating Transport	JSM	Class 1	Microbiology	No	2025-09-30
Real Time Nucleic Acid Amplification System	OOI	Class 2	Clinical Chemistry	No	2025-09-30
Respiratory Virus Panel Nucleic Acid Assay System	OCC	Class 2	Microbiology	No	2025-09-30
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2011-11-10
Assay, Porphyrin, Spectrophotometry, Lithium	NDW	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2011-11-10
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2011-11-10
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2011-11-10
Igm (Mu Chain Specific), Antigen, Antiserum, Control	DAO	Class 2	Immunology	No	2011-11-10
System, Test, Beta-2-Microglobulin Immunological	JZG	Class 2	Immunology	No	2011-11-10
Radioimmunoassay, Methaqualone	KXS	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2011-11-10
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2011-11-10
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	Class 2	Immunology	No	2011-11-10
Enzymatic, Carbon-Dioxide	KHS	Class 2	Clinical Chemistry	No	2011-11-10
Enzymatic Method, Ammonia	JIF	Class 1	Clinical Chemistry	No	2011-11-10
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2011-11-10
Catalytic Methods, Amylase	JFJ	Class 2	Clinical Chemistry	No	2011-11-10
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2011-11-10
System, Test, Low Density, Lipoprotein	MRR	Class 1	Clinical Chemistry	No	2011-11-10
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	Class 1	Clinical Chemistry	No	2011-11-10
Fibrin Split Products	GHH	Class 2	Hematology	No	2011-11-10
Enzyme Immunoassay, Quinidine	LBZ	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2011-11-10
Acid Phosphatase, Disodium Phenylphosphate	CJX	Class 2	Clinical Chemistry	No	2011-11-10
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2011-11-10
Iga, Antigen, Antiserum, Control	CZP	Class 2	Immunology	No	2011-11-10
Amikacin Serum Assay	KLP	Class 2	Clinical Toxicology	No	2011-11-10
Alpha-1-Lipoprotein, Antigen, Antiserum, Control	DER	Class 2	Immunology	No	2011-11-10
Complement C3, Antigen, Antiserum, Control	CZW	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2011-11-10
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2011-11-10
Colorimetry, Acetaminophen	LDP	Class 2	Clinical Toxicology	No	2011-11-10
Immunochemical, Ceruloplasmin	CHN	Class 2	Immunology	No	2011-11-10
Radioimmunoassay, Lsd (125-I)	DLB	Class 2	Clinical Toxicology	No	2011-11-10
Radioimmunoassay, Tobramycin	KLB	Class 2	Clinical Toxicology	No	2011-11-10
Test, Cystatin C	NDY	Class 2	Clinical Chemistry	No	2011-11-10
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Procainamide	LAR	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2011-11-10
Acid, Uric, Uricase (Colorimetric)	KNK	Class 1	Clinical Chemistry	No	2011-11-10
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	No	2011-11-10
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2011-11-10
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	Class 2	Clinical Chemistry	No	2011-11-10
Ferritin, Antigen, Antiserum, Control	DBF	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, N-Acetylprocainamide	LAN	Class 2	Clinical Toxicology	No	2011-11-10
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2011-11-10
Turbidimetric, Total Protein	JGQ	Class 2	Clinical Chemistry	No	2011-11-10
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2011-11-10
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2011-11-10
Complement C4, Antigen, Antiserum, Control	DBI	Class 2	Immunology	No	2011-11-10
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	Class 1	Clinical Chemistry	No	2011-11-10
Colorimetry, Cholinesterase	DIH	Class 1	Clinical Toxicology	No	2011-11-10
Colorimetry, Salicylate	DKJ	Class 2	Clinical Toxicology	No	2011-11-10
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	NQD	Class 2	Immunology	No	2011-11-10
Haptoglobin, Antigen, Antiserum, Control	DAD	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Propoxyphene	JXN	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2011-11-10
Differential Rate Kinetic Method, Cpk Or Isoenzymes	JHS	Class 2	Clinical Chemistry	No	2011-11-10
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method	DML	Class 2	Clinical Toxicology	No	2011-11-10
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2011-11-10
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2011-11-10
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2011-11-10
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2011-11-10
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	No	2011-11-10
Mycophenolic Acid Test System	OAV	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2011-11-10
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2011-11-11
System, Test, Radioallergosorbent (Rast) Immunological	DHB	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Immunoglobulins (D, E)	JHR	Class 2	Immunology	No	2011-11-11
Flame Photometry, Lithium	JIH	Class 2	Clinical Toxicology	No	2013-01-10
Assay, Fetal Hemoglobin	KQI	Class 2	Hematology	No	2011-11-15
Counter, Urine Particle	LKM	Class 2	Hematology	No	2025-09-04
Electrode, Ion Specific, Urea Nitrogen	CDS	Class 2	Clinical Chemistry	No	2009-02-26
System, Multipurpose For In Vitro Coagulation Studies	JPA	Class 2	Hematology	No	2018-01-23
Oxyhemoglobin	GGZ	Class 2	Hematology	No	2021-08-10
Whole Blood Hemoglobin Determination	KHG	Class 2	Hematology	No	2021-08-10
Acid Hematin	GGF	Class 2	Hematology	No	2021-08-10
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	Class 2	Immunology	No	2023-05-09
Test, Time, Prothrombin	GJS	Class 2	Hematology	No	2023-02-01
Biosensor, Immunoassay, Cpk Or Isoenzymes	MYT	Class 2	Clinical Chemistry	No	2023-02-01
Activated Whole Blood Clotting Time	JBP	Class 2	Hematology	No	2023-02-01
Ph Rate Measurement, Carbon-Dioxide	JFL	Class 2	Clinical Chemistry	No	2023-02-01
Electrode, Ion Based, Enzymatic, Creatinine	CGL	Class 2	Clinical Chemistry	No	2023-02-01
Test, Natriuretic Peptide	NBC	Class 2	Clinical Chemistry	No	2023-02-01
Immunoassay Method, Troponin Subunit	MMI	Class 2	Clinical Chemistry	No	2023-02-01
Acid, Uric, Uricase (U.V.)	CDO	Class 1	Clinical Chemistry	No	2011-11-11
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	Class 2	Clinical Chemistry	No	2011-11-11
Mercuric Thiocyanate, Colorimetry, Chloride	CHJ	Class 2	Clinical Chemistry	No	2011-11-11
Acid Phosphatase, Naphthyl Phosphate	CKB	Class 2	Clinical Chemistry	No	2011-11-11
Breast Milk, Rhodamine, Antigen, Antiserum, Control	DGI	Class 1	Immunology	No	2011-11-11
Turbidimetric Method, Lipoproteins	JHN	Class 1	Clinical Chemistry	No	2011-11-11
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control	DEF	Class 1	Immunology	No	2011-11-11
Radioimmunoassay, Immunoglobulins (G, A, M)	CFQ	Class 2	Immunology	No	2011-11-11
Gas Chromatography, Amphetamine	DOD	Class 2	Clinical Toxicology	No	2011-11-11
Atp And Creatine Kinase (Enzymatic), Creatine	JLB	Class 1	Clinical Chemistry	No	2011-11-11
Dna-Reagents, Neisseria	LSL	Class 2	Microbiology	No	2020-06-12
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	Class 1	Microbiology	No	2020-06-12
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	DIC	Class 2	Clinical Toxicology	No	2020-03-27
Calibrators, Drug Mixture	DKB	Class 2	Clinical Toxicology	No	2020-03-27
Lipoprotein X, Antigen, Antiserum, Control	DEL	Class 1	Immunology	No	2020-03-27
Kinetic Method, Gamma-Glutamyl Transpeptidase	JQB	Class 1	Clinical Chemistry	No	2020-03-27
Method, Nephelometric, Immunoglobulins (G, A, M)	CFN	Class 2	Immunology	No	2020-03-27
Fluorescence Polarization Immunoassay, Carbamazepine	LGI	Class 2	Clinical Toxicology	No	2020-03-27
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2020-03-27
Radioassay, Triiodothyronine Uptake	KHQ	Class 2	Clinical Chemistry	No	2020-03-27
Drug Specific Control Materials	LAS	Class 1	Clinical Toxicology	No	2020-03-27
Biuret (Colorimetric), Total Protein	CEK	Class 2	Clinical Chemistry	No	2020-03-27
System, Test, Urinary Methylmalonic Acid	LPT	Class 2	Clinical Chemistry	No	2020-03-27
Nephelometer	JZW	Class 1	Immunology	No	2020-03-27
Fluorescence Polarization Immunoassay, Phenobarbital	LGQ	Class 2	Clinical Toxicology	No	2020-03-27
Drug Mixture Control Materials	DIF	Class 1	Clinical Toxicology	No	2020-03-27
Enzyme Immunoassay, Cocaine	JXO	Class 2	Clinical Toxicology	No	2020-03-27
Igg, Antigen, Antiserum, Control	DEW	Class 2	Immunology	No	2020-03-27
Olive Oil Emulsion (Turbidimetric), Lipase	CET	Class 1	Clinical Chemistry	No	2020-03-27
Fluorescence Polarization Immunoassay, Theophylline	LGS	Class 2	Clinical Toxicology	No	2020-03-27
Calibrators, Drug Specific	DLJ	Class 2	Clinical Toxicology	No	2020-03-27
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)	MOJ	Class 2	Clinical Toxicology	No	2020-03-27
Nadh Oxidation/Nad Reduction, Alt/Sgpt	CKA	Class 1	Clinical Chemistry	No	2020-03-27
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	Class 1	Clinical Chemistry	No	2011-11-11
Urinary Homocystine (Nonquantitative) Test System	LPS	Class 2	Clinical Chemistry	No	2011-11-11
Ige, Antigen, Antiserum, Control	DGC	Class 2	Immunology	No	2011-11-11
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	Class 2	Clinical Toxicology	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2011-11-11
Visual, Pregnancy Hcg, Prescription Use	JHI	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Total Triiodothyronine	CDP	Class 2	Clinical Chemistry	No	2011-11-11
Radioassay, Vitamin B12	CDD	Class 2	Clinical Chemistry	No	2011-11-11
System, Test, Thyroid Autoantibody	JZO	Class 2	Immunology	No	2011-11-11
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Progesterone	JLS	Class 1	Clinical Chemistry	No	2011-11-11
Fluorescent Immunoassay, Tobramycin	LCR	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Luteinizing Hormone	CEP	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Free Thyroxine	CEC	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2011-11-11
Enzyme Immunoassay, Gentamicin	LCD	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Prolactin (Lactogen)	CFT	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Parathyroid Hormone	CEW	Class 2	Clinical Chemistry	No	2011-11-11
Acid, Folic, Radioimmunoassay	CGN	Class 2	Clinical Chemistry	No	2011-11-11
Control, Hematocrit	GLK	Class 2	Hematology	No	2021-01-25
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	Class 1	Clinical Chemistry	No	2011-11-11
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	Class 2	Immunology	No	2011-11-11
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	Class 1	Clinical Chemistry	No	2021-07-19
Automated Urinalysis System	KQO	Class 1	Clinical Chemistry	No	2021-07-19
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	Class 1	Clinical Chemistry	No	2021-07-19
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	Class 1	Clinical Chemistry	No	2021-07-19
Test, Urine Leukocyte	LJX	Class 1	Hematology	No	2021-07-19
Blood, Occult, Colorimetric, In Urine	JIO	Class 2	Hematology	No	2021-07-19
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	Class 1	Clinical Chemistry	No	2021-07-19
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	Class 1	Clinical Chemistry	No	2021-07-19
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	JMA	Class 1	Clinical Chemistry	No	2021-07-19
Refractometer For Clinical Use	JRE	Class 1	Clinical Chemistry	No	2021-07-19
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	Class 2	Clinical Chemistry	No	2021-07-19
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	Class 1	Clinical Chemistry	No	2021-07-19
Clinical Sample Concentrator	JJH	Class 1	Clinical Chemistry	No	2021-08-04
Analyzer, Chemistry, Centrifugal, For Clinical Use	JJG	Class 1	Clinical Chemistry	No	2022-06-21
Colorimetric Method, Cpk Or Isoenzymes	JHY	Class 2	Clinical Chemistry	No	2022-08-11
System, Test, Human Chorionic Gonadotropin	DHA	Class 2	Clinical Chemistry	No	2024-12-27
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	NJR	Class 1	Microbiology	No	2025-09-30
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	Class 2	Microbiology	No	2024-12-27
Influenza A Virus Subtype Differentiation Nucleic Acid Assay	OEP	Class 2	Microbiology	No	2024-12-27
Bordetella Pertussis Dna Assay System	OZZ	Class 2	Microbiology	No	2024-12-27
Non-Sars Coronavirus Multiplex Nucleic Acid Assay	OTG	Class 2	Microbiology	No	2024-12-27
Parainfluenza Multiplex Nucleic Acid Assay	OOU	Class 2	Microbiology	No	2024-12-27
Mycoplasma Pneumoniae Dna Assay System	OZX	Class 2	Microbiology	No	2024-12-27
System, Test, Automated Blood Grouping And Antibody	KSZ	Class 2	Hematology	No	2020-09-01
Flame Emission Photometer For Clinical Use	JJO	Class 1	Clinical Chemistry	No	2011-11-11
Fluorometric, Calcium	JFO	Class 2	Clinical Chemistry	No	2020-08-19
Hemoglobin A2 Quantitation	JPD	Class 2	Hematology	No	2014-05-02
Fluorometer, For Clinical Use	KHO	Class 1	Clinical Chemistry	No	2011-11-10
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	Class 1	Clinical Chemistry	No	2009-02-26
Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment	QFS	Class 2	Microbiology	No	2025-05-01
Helicobacter Pylori	LYR	Class 1	Microbiology	No	2011-11-11
Radioimmunoassay, Immunoreactive Insulin	CFP	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Cyclic Gmp	CGT	Class 2	Clinical Chemistry	No	2011-11-11
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Estriol	CGI	Class 1	Clinical Chemistry	No	2011-11-11
Acid Phosphatase (Prostatic), Tartrate Inhibited	JFH	Class 2	Clinical Chemistry	No	2011-11-11
Column Chromatography & Color Development, Hydroxyproline	JMM	Class 1	Clinical Chemistry	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	Class 2	Microbiology	No	2011-11-11
Albumin, Rhodamine, Antigen, Antiserum, Control	DFJ	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Estradiol	CHP	Class 1	Clinical Chemistry	No	2011-11-11
Gas Chromatography, Methamphetamine	LAF	Class 2	Clinical Toxicology	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	Class 2	Microbiology	No	2011-11-11
System, Test, Immunological, Antigen, Tumor	MOI	Class 2	Immunology	No	2011-11-11
Fluorometric Method, Cpk Or Isoenzymes	JHX	Class 2	Clinical Chemistry	No	2011-11-11
System, Test, Thyroglobulin	MSW	Class 2	Immunology	No	2011-11-11
Enzyme Immunoassay, Digitoxin	LFM	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay (Two-Site Solid Phase), Ferritin	JMG	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Cortisol	CGR	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Acth	CKG	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Thyroxine-Binding Globulin	CEE	Class 2	Clinical Chemistry	No	2011-11-11
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	Class 1	Clinical Chemistry	No	2011-11-11
Enzyme Immunoassay, Carbamazepine	KLT	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Human Placental Lactogen	JMF	Class 2	Clinical Chemistry	No	2011-11-11
Ige, Peroxidase, Antigen, Antiserum, Control	DGO	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Human Growth Hormone	CFL	Class 1	Clinical Chemistry	No	2011-11-11
System, Test, Carcinoembryonic Antigen	DHX	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	Class 1	Clinical Chemistry	No	2011-11-11
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	Class 2	Immunology	No	2011-11-11
Nephelometer, For Clinical Use	JQX	Class 1	Clinical Chemistry	No	2011-11-15
Slide Stainer, Automated	KPA	Class 1	Pathology	No	2011-11-11
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	Class 2	Hematology	No	2024-12-27
Reagent, Borrelia Serological Reagent	LSR	Class 2	Microbiology	No	2024-12-27
Hepatitis A Test (Antibody And Igm Antibody)	LOL	Class 2	Microbiology	No	2020-08-19
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	LON	Class 2	Microbiology	No	2014-05-01
Enzymatic Method, Creatinine	JFY	Class 2	Clinical Chemistry	No	2025-09-30
Instrumentation For Clinical Multiplex Test Systems	NSU	Class 2	Clinical Chemistry	No	2020-08-06

Proprietary Names

Chemistry Analyzer Blood Gas Analyzer Immunology Analyzer CD Cal-Packs HEMATOLOGY ANALYZER Microbiology SMARTLYTE® Electrolyte Analyzer Clinical Chemistry Urine Analyzer BK BUN Linearity Hematology Analyzer CONTROL BK Creatinine CLINCAL CHEMISTRY Chemistry Hema ANALYZER, CHEMISTRY Packs SmartLyte URINALYSIS CLINICAL SAMPLE CONCENTRATOR Mission Reagents Photometric Immunology Glucose Test System Assay System Coagulation Diamond Calibrators for Atac 8000/Envoy 500 ISE Modules Hematology Device CALIBRATOR PROLYTE Test Systems Dade Calibrator Calibrator Urinalysis Analyzer Controls Immunoassay Analyzer Cal-Packs chemistry Hematocrit SmartLyte Plus Electrolyte Analyzer Automated Test System PROLTYE® Electrolyte Analyzer Hematology Diamond Calibrators for Tokyo Boeki ISE Module MICROBIOLOGY ANALYZER BK ISE BK Glucose Immunodiagnostic System Trinity B OY Reagents

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Registrations

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Owner / Operator

Diamond Diagnostics Inc.

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Product Codes

Find other entries with 241 product codes: JGS, JJE, CFR, CEM, CGZ, GHS, JFP, JJY, JIX, GKR, JPI, GLY, CGA, CHL, KHP, MQM, GKF, JIS, LCP, CIC, GKZ, MZA, JJF, GKP, JIT, GKL, JSM, OOI, OCC, DDR, NDW, LCM, CGX, CEO, DAO, JZG, KXS, JXM, CIX, DFC, KHS, JIF, CHH, JFJ, DCF, MRR, LBS, GHH, LBZ, DIP, LEG, CJX, JIY, CZP, KLP, DER, CZW, DJG, DCN, LDP, CHN, DLB, KLB, NDY, DHR, LAR, KXT, KNK, DDG, CIT, CJE, DBF, LAN, CDQ, JGQ, CJW, DLZ, DIS, LEH, DBI, CDT, DIH, DKJ, NQD, DAD, JXN, DKZ, JHS, DML, JGJ, JMO, DEM, DJR, CFJ, CIG, KLS, OAV, DIO, LDJ, CGJ, JLW, DHB, JHR, JIH, KQI, LKM, CDS, JPA, GGZ, KHG, GGF, OUY, GJS, MYT, JBP, JFL, CGL, NBC, MMI, CDO, CGS, CHJ, CKB, DGI, JHN, DEF, CFQ, DOD, JLB, LSL, MKZ, DIC, DKB, DEL, JQB, CFN, LGI, KLI, KHQ, LAS, CEK, LPT, JZW, LGQ, DIF, JXO, DEW, CET, LGS, DLJ, MOJ, CKA, CDZ, LPS, DGC, LGR, LGD, JHI, CDP, CDD, JZO, JJX, JLS, LCR, CEP, CEC, LFX, LCD, CFT, CEW, CGN, GLK, JJQ, DCK, CDM, KQO, JIN, JIR, LJX, JIO, JJB, JMT, JMA, JRE, JIL, CEN, JJH, JJG, JHY, DHA, NJR, OEM, OEP, OZZ, OTG, OOU, OZX, KSZ, JJO, JFO, JPD, KHO, JJS, QFS, LYR, CFP, CGT, LTJ, CGI, JFH, JMM, LFZ, DFJ, CHP, LAF, LGC, MOI, JHX, MSW, LFM, JMG, CGR, CKG, CEE, LTK, JKC, KLT, JMF, DGO, CFL, DHX, JKD, LOJ, JQX, KPA, DAP, LSR, LOL, LON, JFY, NSU

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510(k) Number

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