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

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis (NCD) (8) Kit, Dna Detection, Human Papillomavirus (MAQ) (1) Spatula, Cervical, Cytological (HHT) (1)

Premarket Exempt

Clear

digene® Wash Buffer Concentrate - 14053228002014 Catalog Number : 5100-00047

Device Description : digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate)

Device Class : 3

Duns Number: 008675485

Premarket Exempt : No

Product Code : MAQ

Prescription Use : Yes

Device Count : 1

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - 14053228002120 Catalog Number : 5970403

Device Description : QF-TB Gold Blood collection tubes - Dispenser Pack (25 single patient packs)

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 25

QuantiFERON-TB Gold Blood Collection Tubes Dispenser Pack - High Altitude - 14053228002137 Catalog Number : 5970405

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 25

QuantiFERON-TB Gold Blood Collection Tubes - 14053228002144 Catalog Number : T05900301

Device Description : Bulk pack

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 100

QuantiFERON-TB Gold Blood Collection Tubes - High Altitude - 14053228002151 Catalog Number : T05900505

Device Description : bulk pack

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 100

digene® HC2 DNA Collection Device - 14053228010354 Catalog Number : 619204

Device Class : 2

Duns Number: 008675485

Premarket Exempt : No

Product Code : HHT

Prescription Use : Yes

Device Count : 1

QuantiFERON®-TB Gold Plus - 14053228015885 Catalog Number : 622433

Device Description : QFT-Plus Blood Collection Tubes (25x)

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 25

QuantiFERON®-TB Gold Plus - 14053228015892 Catalog Number : 622536

Device Description : QFT-Plus Blood Collection Tubes (50x)

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 50

QuantiFERON®-TB Gold Plus - 14053228015908 Catalog Number : 623536

Device Description : QFT-Plus High Altitiude Blood Collection Tubes (50x)

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 50

QuantiFERON®-TB Gold Plus - 14053228015915 Catalog Number : 623433

Device Description : QFT-Plus High Altitiude Blood Collection Tubes (25x)

Device Class :

Duns Number: 008675485

Premarket Exempt : No

Product Code : NCD

Prescription Use : Yes

Device Count : 25

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