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 Immunoassasy, Nocotine And Nicotine Metabolites (MKU) (5) Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus (MZO) (2) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (2) Unit, Cryosurgical, Accessories (GEH) (1)

Premarket Exempt

No Yes

Clear

Cotinine Serum 5 Plate Kit - 00608337000399 Catalog Number :

Device Class : 1

Duns Number: 114152184

Premarket Exempt : No

Product Code : MKU

Prescription Use : Yes

Device Count : 1

Cotinine Serum 2 Plate Kit - 00608337000405 Catalog Number :

Device Class : 1

Duns Number: 114152184

Premarket Exempt : No

Product Code : MKU

Prescription Use : Yes

Device Count : 1

Cocaine OraSure 5 Plate Kit - 00608337000412 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Cocaine OraSure 100 Plate Kit - 00608337000429 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

Auto-Lyte - 00608337000474 Catalog Number : 1224UL

Device Description : Auto-Lyte Cotinine Urine 100mL

Device Class : 1

Duns Number: 114152184

Premarket Exempt : No

Product Code : MKU

Prescription Use : Yes

Device Count : 1

OraQuick HCV Rapid Antibody Test - 00608337000535 Catalog Number :

Device Class :

Duns Number: 114152184

Premarket Exempt : No

Product Code : MZO

Prescription Use : Yes

Device Count : 1

OraQuick HCV Rapid Antibody Test Kit Controls - 00608337000542 Catalog Number :

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : MZO

Prescription Use : Yes

Device Count : 1

Histofreezer - 00608337000559 Catalog Number :

Device Description : Histofreezer Kit, U.S., 60MC2 +10

Device Class : 2

Duns Number: 114152184

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cotinine OraSure 5 Plate Kit - 00608337000665 Catalog Number :

Device Class : 1

Duns Number: 114152184

Premarket Exempt : No

Product Code : MKU

Prescription Use : Yes

Device Count : 1

Cotinine OraSure 100 Plate Kit - 00608337000672 Catalog Number :

Device Class : 1

Duns Number: 114152184

Premarket Exempt : No

Product Code : MKU

Prescription Use : Yes

Device Count : 1

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