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, Barbiturate (DIS) (3) Enzyme Immunoassay, Amphetamine (DKZ) (2) Enzyme Immunoassay, Benzodiazepine (JXM) (2) Gas Chromatography, Methamphetamine (LAF) (2) Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device (PJD) (1)

Premarket Exempt

No Yes

Clear

OraSure Oral Fluid Collection Device - 00608337000115 Catalog Number :

Device Class :

Duns Number: 114152184

Premarket Exempt : No

Product Code : PJD

Prescription Use : Yes

Device Count : 1

Amphetamine Intercept 5 Plate Kit - 00608337000146 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Amphetamine Intercept 100 Plate Kit - 00608337000153 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

Methamphetamine Intercept 5 Plate Kit - 00608337000184 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 1

Methamphetamine Intercept 100 Plate Kit - 00608337000191 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : LAF

Prescription Use : Yes

Device Count : 1

Barbiturates Intercept 5 Plate Kit - 00608337000207 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

Barbiturates Intercept 100 Plate Kit - 00608337000214 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

Barbiturates Intercept 2 Plate Kit - 00608337000221 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIS

Prescription Use : Yes

Device Count : 1

Benzodiazepine Intercept 5 Plate Kit - 00608337000238 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

Benzodiazepine Intercept 100 Plate Kit - 00608337000245 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

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