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: K041133

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
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
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2011-11-11
Ige, Antigen, Antiserum, Control	DGC	Class 2	Immunology	No	2011-11-11
Visual, Pregnancy Hcg, Prescription Use	JHI	Class 2	Clinical Chemistry	No	2011-11-11
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)	LGR	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Total Triiodothyronine	CDP	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2011-11-11
Radioimmunoassay, Progesterone	JLS	Class 1	Clinical Chemistry	No	2011-11-11
Calibrators, Drug Mixture	DKB	Class 2	Clinical Toxicology	No	2011-11-11
Radioassay, Vitamin B12	CDD	Class 2	Clinical Chemistry	No	2011-11-11
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	Class 1	Clinical Chemistry	No	2011-11-11
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Vancomycin	LEH	Class 2	Clinical Toxicology	No	2011-11-11
System, Test, Thyroid Autoantibody	JZO	Class 2	Immunology	No	2011-11-11
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2011-11-11
Radioassay, Triiodothyronine Uptake	KHQ	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2011-11-11
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2011-11-11
Fluorescent Immunoassay, Tobramycin	LCR	Class 2	Clinical Toxicology	No	2011-11-11
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	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
Fluorescence Polarization Immunoassay, Theophylline	LGS	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Parathyroid Hormone	CEW	Class 2	Clinical Chemistry	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
Acid, Folic, Radioimmunoassay	CGN	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	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