ALERE NORTH AMERICA, LLC

ALERE NORTH AMERICA, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antigens, Nontreponemal, All (GMQ) (7) Reagent, Occult Blood (KHE) (1) System, Test, C-Reactive Protein (DCN) (1) System, Test, Rheumatoid Factor (DHR) (1)

Premarket Exempt

No Yes

Clear

RHEUMATEX® - 10859035006009 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : Yes

Product Code : DHR

Prescription Use : Yes

Device Count : 100

IMMUNEX CRP® - 10859035006016 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : Yes

Product Code : DCN

Prescription Use : Yes

Device Count : 100

DENCOCCULT™ III - 10859035006023 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : Yes

Product Code : KHE

Prescription Use : Yes

Device Count : 100

IMPACT RPR™ TEST KIT (50 TESTS) - 10859035006030 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 50

IMPACT RPR™ TEST KIT (150 TESTS) - 10859035006047 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 150

IMPACT RPR™ TEST KIT (500 TESTS) - 10859035006054 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 500

IMPACT RPR™ TEST KIT (5000 TESTS) - 10859035006061 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 5000

IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS) - 10859035006078 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 5000

IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML - 10859035006085 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 3

IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML - 10859035006092 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 10

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