QIAGEN SCIENCES INC.

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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

Kit, Dna Detection, Human Papillomavirus (MAQ) (4) Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis (NCD) (4) Dna-Reagents, Neisseria (LSL) (2)

Premarket Exempt

Clear

hc2 High-Risk HPV DNA Test - 04053228002000 Catalog Number : 5199-00016

Device Description : digene® HC2 High-Risk HPV DNA Test (4-Plate Kit)

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : MAQ

Prescription Use : Yes

Device Count : 1

hc2 HPV DNA Test - 04053228002024 Catalog Number : 5198-1220

Device Description : digene® HC2 HPV DNA Test (Low-Risk HPV and High-Risk HPV)

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : MAQ

Prescription Use : Yes

Device Count : 1

hc2 High-Risk HPV DNA Test - 04053228002031 Catalog Number : 5199-1220

Device Description : digene® HC2 High-Risk HPV DNA Test (1-Plate Kit)

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : MAQ

Prescription Use : Yes

Device Count : 1

QuantiFERON-TB Gold 2 Plate Kit - 04053228002109 Catalog Number : 5940201

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 1

QuantiFERON-TB Gold Reference Lab Pack - 04053228002116 Catalog Number : 5940501

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 1

digene® HC2 CT/GC DNA Test - 04053228010265 Catalog Number : 5130-1220

Device Class : 2

Duns Number: 008675485

Premarket Exempt : No

Product Code : LSL

Prescription Use : Yes

Device Count : 1

digene® HC2 GC-ID DNA Test - 04053228010296 Catalog Number : 5140-1220

Device Class : 2

Duns Number: 008675485

Premarket Exempt : No

Product Code : LSL

Prescription Use : Yes

Device Count : 1

DML 3000 - 04053228010777 Catalog Number : 5000-00031

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : MAQ

Prescription Use : Yes

Device Count : 1

QuantiFERON®-TB Gold Plus - 04053228015864 Catalog Number : 622130

Device Description : QFT-Plus 2 Plate Elisa Kit

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 1

QuantiFERON®-TB Gold Plus - 04053228015871 Catalog Number : 622832

Device Description : QFT-Plus Reference Lab Pack Elisa Kit

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 1

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