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: K100853

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
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2011-11-10
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2011-11-10
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2011-11-10
System, Test, Beta-2-Microglobulin Immunological	JZG	Class 2	Immunology	No	2011-11-10
Igm (Mu Chain Specific), Antigen, Antiserum, Control	DAO	Class 2	Immunology	No	2011-11-10
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	Class 1	Clinical Chemistry	No	2011-11-10
Radioimmunoassay, Methaqualone	KXS	Class 2	Clinical Toxicology	No	2011-11-10
Assay, Porphyrin, Spectrophotometry, Lithium	NDW	Class 2	Clinical Toxicology	No	2011-11-10
Acid, Lactic, Enzymatic Method	KHP	Class 1	Clinical Chemistry	No	2011-11-10
System, Test, Low Density, Lipoprotein	MRR	Class 1	Clinical Chemistry	No	2011-11-10
Albumin, Antigen, Antiserum, Control	DCF	Class 2	Immunology	No	2011-11-10
Bromcresol Green Dye-Binding, Albumin	CIX	Class 2	Clinical Chemistry	No	2011-11-10
Hexokinase, Glucose	CFR	Class 2	Clinical Chemistry	No	2011-11-10
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2011-11-10
Enzymatic Method, Ammonia	JIF	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
Catalytic Methods, Amylase	JFJ	Class 2	Clinical Chemistry	No	2011-11-10
Enzymatic Esterase--Oxidase, Cholesterol	CHH	Class 1	Clinical Chemistry	No	2011-11-10
Enzymatic, Carbon-Dioxide	KHS	Class 2	Clinical Chemistry	No	2011-11-10
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	Class 2	Immunology	No	2011-11-10
Acid Phosphatase, Disodium Phenylphosphate	CJX	Class 2	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Quinidine	LBZ	Class 2	Clinical Toxicology	No	2011-11-10
Amikacin Serum Assay	KLP	Class 2	Clinical Toxicology	No	2011-11-10
Iga, Antigen, Antiserum, Control	CZP	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2011-11-10
Fibrin Split Products	GHH	Class 2	Hematology	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
Enzyme Immunoassay, Procainamide	LAR	Class 2	Clinical Toxicology	No	2011-11-10
Radioimmunoassay, Tobramycin	KLB	Class 2	Clinical Toxicology	No	2011-11-10
Transferrin, Antigen, Antiserum, Control	DDG	Class 2	Immunology	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
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2011-11-10
Assay, Glycosylated Hemoglobin	LCP	Class 2	Hematology	No	2011-11-10
Cresolphthalein Complexone, Calcium	CIC	Class 2	Clinical Chemistry	No	2011-11-10
Ferritin, Antigen, Antiserum, Control	DBF	Class 2	Immunology	No	2011-11-10
Colorimetry, Acetaminophen	LDP	Class 2	Clinical Toxicology	No	2011-11-10
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2011-11-10
Turbidimetric, Total Protein	JGQ	Class 2	Clinical Chemistry	No	2011-11-10
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	Class 2	Clinical Chemistry	No	2011-11-10
Nadh Oxidation/Nad Reduction, Ast/Sgot	CIT	Class 2	Clinical Chemistry	No	2011-11-10
System, Test, Rheumatoid Factor	DHR	Class 2	Immunology	No	2011-11-10
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2011-11-10
Test, Cystatin C	NDY	Class 2	Clinical Chemistry	No	2011-11-10
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	CJE	Class 2	Clinical Chemistry	No	2011-11-10
Photometric Method, Iron (Non-Heme)	JIY	Class 1	Clinical Chemistry	No	2011-11-10
Acid, Uric, Uricase (Colorimetric)	KNK	Class 1	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, N-Acetylprocainamide	LAN	Class 2	Clinical Toxicology	No	2011-11-10
Haptoglobin, Antigen, Antiserum, Control	DAD	Class 2	Immunology	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
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	CFJ	Class 2	Clinical Chemistry	No	2011-11-10
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	CDT	Class 1	Clinical Chemistry	No	2011-11-10
Ferrozine (Colorimetric) Iron Binding Capacity	JMO	Class 1	Clinical Chemistry	No	2011-11-10
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	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
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2011-11-10
Alpha-1-Antitrypsin, Antigen, Antiserum, Control	DEM	Class 2	Immunology	No	2011-11-10
Complement C4, Antigen, Antiserum, Control	DBI	Class 2	Immunology	No	2011-11-10
Colorimetry, Cholinesterase	DIH	Class 1	Clinical Toxicology	No	2011-11-10
Bromcresol Purple Dye-Binding, Albumin	CJW	Class 2	Clinical Chemistry	No	2011-11-10
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2011-11-10
Photometric Method, Magnesium	JGJ	Class 1	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Propoxyphene	JXN	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Phenobarbital	DLZ	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2011-11-10
Diazo Colorimetry, Bilirubin	CIG	Class 2	Clinical Chemistry	No	2011-11-10
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2011-11-10
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2011-11-10
Mycophenolic Acid Test System	OAV	Class 2	Clinical Toxicology	No	2011-11-10
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	No	2011-11-10

Proprietary Names

Analyzer

Establishment Types

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

FDA Registrations

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Owner / Operator

Diamond Diagnostics Inc.

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Product Codes

Find other entries with 78 product codes: CGX, LCM, JXM, DDR, JZG, DAO, CEO, KXS, NDW, KHP, MRR, DCF, CIX, CFR, CEM, JIF, LBS, JFJ, CHH, KHS, DFC, CJX, DIP, LBZ, KLP, CZP, LEG, GHH, DER, CZW, DJG, LAR, KLB, DDG, CHN, DLB, CGZ, LCP, CIC, DBF, LDP, LEH, JGQ, CDQ, CIT, DHR, KXT, NDY, CJE, JIY, KNK, LAN, DAD, DKJ, NQD, CFJ, CDT, JMO, JJE, JHS, DML, DIS, DKZ, DEM, DBI, DIH, CJW, DCN, JGJ, DJR, JXN, DLZ, LDJ, CIG, DIO, JGS, OAV, KLS

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510(k) Number

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