Analyzer

Reg #: 3006198300 · FEI: 3006198300 · Expires 2025

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Diamond Diagnostics Inc.
Registration Number: 3006198300
FEI Number: 3006198300
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: 6 Oradna Street
City: Budapest
Country: HU

Regulatory Submissions

510(k) Number: K981743

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
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	CGS	Class 2	Clinical Chemistry	No	2011-11-11
Complement C3, Antigen, Antiserum, Control	CZW	Class 2	Immunology	No	2011-11-11
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2011-11-11
Acid Phosphatase, Naphthyl Phosphate	CKB	Class 2	Clinical Chemistry	No	2011-11-11
Acid, Uric, Uricase (U.V.)	CDO	Class 1	Clinical Chemistry	No	2011-11-11
Mercuric Thiocyanate, Colorimetry, Chloride	CHJ	Class 2	Clinical Chemistry	No	2011-11-11
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2011-11-11
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	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
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2011-11-11
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2011-11-11
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2011-11-11
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2011-11-11
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2011-11-11
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2011-11-11
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2011-11-11
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2011-11-11
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2011-11-11
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Immunoglobulins (G, A, M)	CFQ	Class 2	Immunology	No	2011-11-11
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2011-11-11
Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control	DEF	Class 1	Immunology	No	2011-11-11
Gas Chromatography, Amphetamine	DOD	Class 2	Clinical Toxicology	No	2011-11-11
Catalytic Methods, Amylase	JFJ	Class 2	Clinical Chemistry	No	2011-11-11
Atp And Creatine Kinase (Enzymatic), Creatine	JLB	Class 1	Clinical Chemistry	No	2011-11-11
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2011-11-11
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2011-11-11
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2011-11-11

Proprietary Names

Analyzer

Establishment Types

Export Device to the United States But Perform No Other Operation on Device