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Genabio Diagnostics, Inc.

USA · Bedford

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

26listed device types

Class I 10Class II 15Class III 0unclassified 1

plus 15 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States15 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: GENABIO DIAGNOSTICS INC

FDA 510(k) clearances by year

12024 · K240545

12025 · K251753

FDA listed device types

showing 8 of 26

Kit, Test, Pregnancy, Hcg, Over The Counter 1Reagent, Occult Blood 1Enzyme Immunoassay, Opiates 1Test, Opiates, Over The Counter 1Enzyme Immunoassay, Benzodiazepine 1Radioimmunoassay, Tricyclic Antidepressant Drugs 1Multi-Analyte Respiratory Virus Antigen Detection Test 1Enzyme Immunoassay, Amphetamine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251753	GenaCheck COVID-19 Rapid Self-Test	2025-09-05
US	K240545	GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)	2024-08-28

Genabio Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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