Gamma Biologicals, Inc.

United StatesFDA applicant, unverified

Devices: 21

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices

Gamma Lewis Blood Group Substance Ref K802533

Active Regimes: 510(k) Registry: 510(k) Class:II
Reagent, Lyophilized Anti-Streptolysin O Ref K760096

Active Regimes: 510(k) Registry: 510(k) Class:I
Rst-Series Control Ref K800658

Active Regimes: 510(k) Registry: 510(k) Class:II
Disposable Test Cards/Gamma Slide Test Infect Mono Ref K864207

Active Regimes: 510(k) Registry: 510(k) Class:II
Gamma Pi Blood Group Substance Ref K802534

Active Regimes: 510(k) Registry: 510(k) Class:II
Lo-Ion Ref K790973

Active Regimes: 510(k) Registry: 510(k) Class:II
Test, Antibodies For Grp A, Latex Slide Ref K760033

Active Regimes: 510(k) Registry: 510(k) Class:I
Fe-Cult Plus Ref K811752

Active Regimes: 510(k) Registry: 510(k) Class:II
Test, C-Reative Protein, Latex Slide Ref K760035

Active Regimes: 510(k) Registry: 510(k) Class:II
Reagent, Vdrl Ref K760098

Active Regimes: 510(k) Registry: 510(k) Class:II
Fe-Cult Plus Ref K820072

Active Regimes: 510(k) Registry: 510(k) Class:II
Gamma Fetal Bleed Screening Test Ref K820647

Active Regimes: 510(k) Registry: 510(k) Class:II
Test, Mono., Differential Slide Ref K760032

Active Regimes: 510(k) Registry: 510(k) Class:I
Gamma Arachis Hypogea Lectin Ref K792583

Active Regimes: 510(k) Registry: 510(k) Class:II
Gamma Chloroquine Diphosphate Solution Ref K813342

Active Regimes: 510(k) Registry: 510(k) Class:II
Gamma Slide Test For Pregnancy Ref K832473

Active Regimes: 510(k) Registry: 510(k) Class:II
Gamma Slide Test For Infectious Mononucleosis Ref K861016

Active Regimes: 510(k) Registry: 510(k) Class:II
Test, Latex Slide, Rheumatoid Factor Ref K760036

Active Regimes: 510(k) Registry: 510(k) Class:II
Poly-Lec System Ref K792582

Active Regimes: 510(k) Registry: 510(k) Class:II
Febrile Antigens & Control Serums Ref K760097

Active Regimes: 510(k) Registry: 510(k) Class:I
Test, Strep, Latex Slide Ref K760034

Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-21 of 21

Frequently asked questions

How many devices does Gamma Biologicals, Inc. have in the registry?

The registry currently lists 21 devices for Gamma Biologicals, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gamma Biologicals, Inc.'s devices?

Among its 21 most recently registered devices, Gamma Biologicals, Inc. has devices listed in FDA 510(k) (21 devices).

What risk classes do Gamma Biologicals, Inc.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Gamma Biologicals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gamma Biologicals, Inc. in the registry?

The most recently registered devices listed for Gamma Biologicals, Inc. include GAMMA LEWIS BLOOD GROUP SUBSTANCE, REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O, RST-SERIES CONTROL and DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO.

Generated automatically from registry data and not verified by a human reviewer.

Catalogue21

Gamma Lewis Blood Group Substance Ref K802533

Reagent, Lyophilized Anti-Streptolysin O Ref K760096

Rst-Series Control Ref K800658

Disposable Test Cards/Gamma Slide Test Infect Mono Ref K864207

Gamma Pi Blood Group Substance Ref K802534

Lo-Ion Ref K790973

Test, Antibodies For Grp A, Latex Slide Ref K760033

Fe-Cult Plus Ref K811752

Test, C-Reative Protein, Latex Slide Ref K760035

Reagent, Vdrl Ref K760098

Fe-Cult Plus Ref K820072

Gamma Fetal Bleed Screening Test Ref K820647

Test, Mono., Differential Slide Ref K760032

Gamma Arachis Hypogea Lectin Ref K792583

Gamma Chloroquine Diphosphate Solution Ref K813342

Gamma Slide Test For Pregnancy Ref K832473

Gamma Slide Test For Infectious Mononucleosis Ref K861016

Test, Latex Slide, Rheumatoid Factor Ref K760036

Poly-Lec System Ref K792582

Febrile Antigens & Control Serums Ref K760097

Test, Strep, Latex Slide Ref K760034

Frequently asked questions