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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: K022603

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
Enzyme Immunoassay, Diphenylhydantoin	DIP	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Prolactin (Lactogen)	CFT	Class 1	Clinical Chemistry	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
Enzyme Immunoassay, Digoxin	KXT	Class 2	Clinical Toxicology	No	2011-11-11
Helicobacter Pylori	LYR	Class 1	Microbiology	No	2011-11-11
System, Test, Human Chorionic Gonadotropin	DHA	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
Column Chromatography & Color Development, Hydroxyproline	JMM	Class 1	Clinical Chemistry	No	2011-11-11
Radioassay, Vitamin B12	CDD	Class 2	Clinical Chemistry	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
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	Class 1	Clinical Chemistry	No	2011-11-11
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2011-11-11
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	Class 2	Microbiology	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	Class 2	Microbiology	No	2011-11-11
Radioimmunoassay, Immunoglobulins (D, E)	JHR	Class 2	Immunology	No	2011-11-11
Immunoassay Method, Troponin Subunit	MMI	Class 2	Clinical Chemistry	No	2011-11-11
Albumin, Rhodamine, Antigen, Antiserum, Control	DFJ	Class 2	Immunology	No	2011-11-11
System, Test, Beta-2-Microglobulin Immunological	JZG	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Total Triiodothyronine	CDP	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay (Two-Site Solid Phase), Ferritin	JMG	Class 2	Immunology	No	2011-11-11
Fluorometric Method, Cpk Or Isoenzymes	JHX	Class 2	Clinical Chemistry	No	2011-11-11
Gas Chromatography, Methamphetamine	LAF	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Acth	CKG	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Immunoassay, Digitoxin	LFM	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Progesterone	JLS	Class 1	Clinical Chemistry	No	2011-11-11
System, Test, C-Reactive Protein	DCN	Class 2	Immunology	No	2011-11-11
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	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
Radioimmunoassay, Estradiol	CHP	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Parathyroid Hormone	CEW	Class 2	Clinical Chemistry	No	2011-11-11
System, Test, Immunological, Antigen, Tumor	MOI	Class 2	Immunology	No	2011-11-11
System, Test, Thyroglobulin	MSW	Class 2	Immunology	No	2011-11-11
System, Test, Thyroid Autoantibody	JZO	Class 2	Immunology	No	2011-11-11
System, Test, Radioallergosorbent (Rast) Immunological	DHB	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	Class 1	Clinical Chemistry	No	2011-11-11
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	Class 2	Microbiology	No	2011-11-11
Radioimmunoassay, Cortisol	CGR	Class 2	Clinical Chemistry	No	2011-11-11
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	Class 1	Clinical Chemistry	No	2011-11-11
Acid, Folic, Radioimmunoassay	CGN	Class 2	Clinical Chemistry	No	2011-11-11
Ige, Peroxidase, Antigen, Antiserum, Control	DGO	Class 2	Immunology	No	2011-11-11
Enzyme Immunoassay, Theophylline	KLS	Class 2	Clinical Toxicology	No	2011-11-11
Enzyme Immunoassay, Valproic Acid	LEG	Class 2	Clinical Toxicology	No	2011-11-11
Radioimmunoassay, Human Placental Lactogen	JMF	Class 2	Clinical Chemistry	No	2011-11-11
Urinary Homocystine (Nonquantitative) Test System	LPS	Class 2	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Thyroxine-Binding Globulin	CEE	Class 2	Clinical Chemistry	No	2011-11-11
Enzyme Immunoassay, Carbamazepine	KLT	Class 2	Clinical Toxicology	No	2011-11-11
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	Class 2	Immunology	No	2011-11-11
Myoglobin, Antigen, Antiserum, Control	DDR	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Free Thyroxine	CEC	Class 2	Clinical Chemistry	No	2011-11-11
System, Test, Carcinoembryonic Antigen	DHX	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, Luteinizing Hormone	CEP	Class 1	Clinical Chemistry	No	2011-11-11
Kit, Test,Alpha-Fetoprotein For Testicular Cancer	LOJ	Class 2	Immunology	No	2011-11-11
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	Class 1	Clinical Chemistry	No	2011-11-11
Radioimmunoassay, Human Growth Hormone	CFL	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

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Owner / Operator

Diamond Diagnostics Inc.

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Product Codes

Find other entries with 59 product codes: DIP, CFT, CFP, CGT, KXT, LYR, DHA, LTJ, JMM, CDD, CGI, JFH, CDZ, LDJ, DKZ, LFZ, LGD, JHR, MMI, DFJ, JZG, CDP, CGJ, JMG, JHX, LAF, CKG, LFM, JLS, DCN, DIO, LGC, CHP, CEW, MOI, MSW, JZO, DHB, JKC, KLI, LFX, CGR, JJE, CGN, DGO, KLS, LEG, JMF, LPS, CEE, KLT, LTK, DDR, CEC, DHX, CEP, LOJ, JKD, CFL

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