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) (9) System, Test, Infectious Mononucleosis (KTN) (1)

Premarket Exempt

Yes No

Clear

IMPACT RPR™ DRY CONTROL CARDS 10 EA - 10859035006108 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 10

IMPACT RPR™ LIQUID CONTROL 3 X 1 ML - 10859035006115 Catalog Number :

Device Class : 2

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

IMPACT RPR™ PIPETS/STIRRERS 500 EA - 10859035006122 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 500

IMPACT RPR™ 10 WELL TEST CARDS 300 EA - 10859035006139 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 300

IMPACT RPR™ 30 WELL TEST CARDS 100 EA - 10859035006146 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 100

IMPACT RPR™ NEEDLE/SHEATH 10 EA - 10859035006153 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 10

IMPACT RPR™ DISPENSING BOTTLES 10 EA - 10859035006160 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 10

IMPACT RPR™ PIPETS/STIRRERS 250 EA - 10859035006177 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 250

IMPACT RPR™ 10 WELL TEST CARDS 50 EA - 10859035006184 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 50

Wampole ColorCard® Mono - 10859035006191 Catalog Number :

Device Class :

Duns Number: 826027364

Premarket Exempt : Yes

Product Code : KTN

Prescription Use : Yes

Device Count : 50

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