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Genabio Diagnostics Inc.

Last updated September 17, 2026

Information

Country: US
Address: 19 Crosby Dr. Ste 220, Bedford, MA, 01730
Website: genabio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-614-3365
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3016609999
DUNS Number: 118586095

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
GenaCheck Vaginal pH Screening Test	RA9-E02303	FDA UDI	Class I	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00301	FDA UDI	N	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00301	FDA UDI	N	Active
GenaCheck Alcohol Rapid Self-Test Kit	RA9-E01905	FDA UDI	Class II	Active
GenaCheck®PdG At-Home Ovulation Confirmation Test	N/A	FDA UDI	Class I	Active
GenaCheck® Nitrile Powder Free Examination Glove	N/A	FDA UDI	Class I	Active
GenaCheck® Nitrile Powder Free Examination Glove	N/A	FDA UDI	Class I	Active
GenaCheck®LH At-Home Ovulation Prediction Test	N/A	FDA UDI	Class I	Active
GenaCheck 12-Drug Rapid Self-Test Kit	RA9-E01902	FDA UDI	Class II	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00325	FDA UDI	N	Active
GenaCheck COVID-19 / Flu Rapid Self-Test Kit	RA9-E02401	FDA UDI	N	Active
GenaCheck Rapid Self-Test Kit for FOB	RA9-E01701	FDA UDI	Class II	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00305	FDA UDI	N	Active
GenaCheck® COVID-19/Flu A&B Rapid Self-Test	RA9-E02404	FDA UDI	Class II	Active
GenaCheck® Early Result Pregnancy Test	N/A	FDA UDI	Class II	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00305	FDA UDI	N	Active
GenaCheck® FSH At-Home Menopause Test	N/A	FDA UDI	Class I	Active
GenaCheck® Nitrile Powder Free Examination Glove	N/A	FDA UDI	Class I	Active
GenaCheck COVID-19 / Flu Rapid Self-Test Kit	RA9-E02501	FDA UDI	N	Active
GenaCheck® Nitrile Powder Free Examination Glove	N/A	FDA UDI	Class I	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00325	FDA UDI	N	Active
GenaCheck™ Fentanyl Urine Home-Use Test Cassette	RA9-E02525	FDA UDI	Class II	Active
GenaCheck Nitrile Exam Gloves	ZC8-E19700	FDA UDI	Class I	Active
GenaCheck 5-Drug Rapid Self-Test Kit	RA9-E02105	FDA UDI	Class II	Active
GenaCheck® COVID-19/Flu A&B Rapid Self-Test	RA9-E02402	FDA UDI	Class II	Active
GenaCheck Rapid Self-Test Kit For Urinary Tract Infections	RA9-E01802	FDA UDI	Class I	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00302	FDA UDI	N	Active
GenaCheck®Fentanyl Urine Test Cassette	N/A	FDA UDI	N/A	Active
Genabio COVID-19 Rapid Self-Test Kit	N/A	FDA UDI	N	Active
Genabio COVID-19 Rapid Self-Test Kit	RA9-E00302	FDA UDI	N	Active
GenaCheck Rapid Self-Test Kit For Cannabis	RA9-E02005	FDA UDI	Class II	Active
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)	K240545	FDA 510(k)	Class I	Active
GenaCheck COVID-19 Rapid Self-Test	K251753	FDA 510(k)	Class II	Active

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