IMMUNOSTICS COMPANY, INC

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Device Description : A rapid, one step screening test for the simultaneous, qualitative detection of A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DJR, DIO, LAF, JXM, LDJ, DKZ, DJG, DIS, LCM

Prescription Use : Yes

Device Count : 25

Device Description : A rapid, one step screening test for the simultaneous, qualitative detection of A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LCM, DIS, JXM, DJG, LDJ, LAF, DJR, DKZ, DIO

Prescription Use : Yes

Device Count : 25

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 125

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : No

Device Count : 3

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

Device Description : For the qualitative detection of hCG in urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Device Description : For the qualitative detection of hCG in urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Device Description : Home pregnancy test for early results

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 25

Device Description : For rapid detection of multiple analytes in human urine.

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JIL, JIO, LJX, CDM, CEN, JIR, JRE, JIN, JMT, JJB, JMA

Prescription Use : Yes

Device Count : 100

Device Description : For rapid detection of multiple analytes in human urine.

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JIR, JRE, CDM, JMA, JMT, JIN, LJX, JIL, JIO, CEN, JJB

Prescription Use : Yes

Device Count : 100