DIAMOND DIAGNOSTICS Inc

Registration Details

Registration Name: DIAMOND DIAGNOSTICS Inc
Registration Number: 3003030793
FEI Number: 3003030793
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 333 Fiske St
City: Holliston
State: MA
ZIP: 01746
Country: US

Regulatory Submissions

510(k) Number: K082462

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

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrode, Ion Specific, Sodium	JGS	Class 2	Clinical Chemistry	No	2009-02-26
Electrode, Ion Specific, Potassium	CEM	Class 2	Clinical Chemistry	No	2009-02-26
Flame Photometry, Lithium	JIH	Class 2	Clinical Toxicology	No	2009-02-26
Electrode, Ion Specific, Calcium	JFP	Class 2	Clinical Chemistry	No	2009-02-26
Electrode, Ion-Specific, Chloride	CGZ	Class 2	Clinical Chemistry	No	2009-02-26
Calibrator, Secondary	JIT	Class 2	Clinical Chemistry	No	2009-02-26
Calibrator, Multi-Analyte Mixture	JIX	Class 2	Clinical Chemistry	No	2009-02-26
Multi-Analyte Controls, All Kinds (Assayed)	JJY	Class 1	Clinical Chemistry	No	2010-09-10
Electrode, Ion Specific, Urea Nitrogen	CDS	Class 2	Clinical Chemistry	No	2009-02-26
Glucose Oxidase, Glucose	CGA	Class 2	Clinical Chemistry	No	2009-02-26
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	Class 1	Clinical Chemistry	No	2009-02-26
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	LON	Class 2	Microbiology	No	2014-05-01
Real Time Nucleic Acid Amplification System	OOI	Class 2	Clinical Chemistry	No	2024-12-27
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	NQX	Class 2	Microbiology	No	2024-12-27
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	Class 2	Clinical Chemistry	No	2024-12-27
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	Class 1	Clinical Chemistry	No	2024-12-27
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	Class 2	Hematology	No	2024-12-27
Visual, Pregnancy Hcg, Prescription Use	JHI	Class 2	Clinical Chemistry	No	2024-12-27
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2024-12-27
Helicobacter Pylori	LYR	Class 1	Microbiology	No	2024-12-27
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2024-12-27
Reagent, Borrelia Serological Reagent	LSR	Class 2	Microbiology	No	2024-12-27
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2024-12-27
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
Respiratory Virus Panel Nucleic Acid Assay System	OCC	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, Blood Culturing	MDB	Class 1	Microbiology	No	2024-12-27
Alkaline Picrate, Colorimetry, Creatinine	CGX	Class 2	Clinical Chemistry	No	2009-02-26

Proprietary Names

SmartLyte CD Cal-Packs Mission Reagents BK ISE Analyzer Cal-Packs BK BUN Dade Calibrator BK Glucose Controls SMARTLYTE® Electrolyte Analyzer OY Reagents Diamond Calibrators for Tokyo Boeki ISE Module Trinity B Automated Test System PROLYTE Packs CALIBRATOR Molecular Linearity CONTROL Immunology Calibrator PROLTYE® Electrolyte Analyzer Microbiology Diamond Calibrators for Atac 8000/Envoy 500 ISE Modules SmartLyte Plus Electrolyte Analyzer BK Creatinine

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)