Orasure Technologies, Inc.

Address:220 EAST FIRST STREET,BETHLEHEM,PA,18015,US

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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

Enzyme Immunoassay, Opiates (DJG) (4) Enzyme Immunoassay, Phencyclidine (LCM) (3) Container, Specimen Mailer And Storage, Non-Sterile (NNK) (1) System,Test,Home,Hiv-1 (MVZ) (1) Test, Hiv Detection (MZF) (1)

Premarket Exempt

No Yes

Clear

Opiates Serum 5 plate Kit - 00608337000689 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Opiates Serum 2 Plate Kit - 00608337000696 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Opiates Intercept 5 Plate Kit - 00608337000702 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

Opiates Intercept 100 Plate Kit - 00608337000719 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

PCP Intercept 5 Plate Kit - 00608337000726 Catalog Number :

Device Class : U

Duns Number: 114152184

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

PCP Intercept 100 Plate Kit - 00608337000733 Catalog Number :

Device Class : U

Duns Number: 114152184

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

PCP Intercept 2 Plate Kit - 00608337000740 Catalog Number :

Device Class : U

Duns Number: 114152184

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

OraSure HIV-1 Western Blot Kit - 00608337000863 Catalog Number :

Device Class : 3

Duns Number: 114152184

Premarket Exempt : No

Product Code : MVZ

Prescription Use : Yes

Device Count : 1

Intercept i2 Oral Fluid Collection Device - 00608337000917 Catalog Number :

Device Class :

Duns Number: 114152184

Premarket Exempt : Yes

Product Code : NNK

Prescription Use : Yes

Device Count : 1

OraQuick In Home HIV Test (Not for Resale) - 00608337000962 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : MZF

Prescription Use : No

Device Count : 1

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