FDA.reportPublic FDA data

GENABIO DIAGNOSTICS INC

Matched from indexed company URL: Genabio Diagnostics Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30166099993016609999GENABIO DIAGNOSTICS INC1Y2026-01-0119 Crosby Dr. Ste 220 Bedford MA US 01730

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008954800GenaCheck™ Fentanyl Urine Home-Use Test Cassette - RA9-E025251-800-614-3365info@genabio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2403411189351166K251753GenaCheck COVID-19 Rapid Self-TestQYT2025-09-05
2403411232429006K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCX2024-06-21
2403411859233400K240545GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL)LZA2024-08-28
2403412028835619K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
2403411072461699K231045Healgen URS Test StripsLJX2023-06-16
2403411627943674K222907Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2023-01-04
2403411610872917K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM2017-08-02
2403411028968221K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)DJG2015-01-27
2403411492514998K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTLDJ2014-06-06
2403412050000658K110309FOB ONE STEP RAPID TESTKHE2011-09-14
2403411448995479DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestSCA2024-10-07
2403411167175470
2403411352095330
2403411604099229
2403411823657964

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA22024-08-28
QYT12025-09-05
SCA12024-10-07
LCX12024-06-21
NGL12023-10-26
LJX12023-06-16
JXM12017-08-02
DJG12015-01-27
LDJ12014-06-06
KHE12011-09-14

PMN#

GUDID#