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, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (3) Enzyme Immunoassay, Methadone (DJR) (3) Enzyme Immunoassay, Benzodiazepine (JXM) (1)

Premarket Exempt

No Yes

Clear

Benzodiazepine Intercept 2 Plate Kit - 00608337000252 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : JXM

Prescription Use : Yes

Device Count : 1

Cannabinoids Intercept 5 Plate Kit - 00608337000269 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

Cannabinoids Intercept 100 Plate Kit - 00608337000276 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

Cannabinoids Intercept 2 Plate Kit - 00608337000283 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

Cocaine Intercept 5 Plate Kit - 00608337000290 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Cocaine Intercept 100 Plate Kit - 00608337000306 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Cocaine Intercept 2 Plate Kit - 00608337000313 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Methadone Intercept 5 Plate Kit - 00608337000320 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

Methadone Intercept 100 Plate Kit - 00608337000337 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

Methadone Intercept 2 Plate Kit - 00608337000344 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DJR

Prescription Use : Yes

Device Count : 1

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