IMMUNOSTICS COMPANY, INC

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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

REAGENT, OCCULT BLOOD (KHE) (6) METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE) (JIL) (3) INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) (JIR) (3) DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) (JMT) (2) TEST, URINE LEUKOCYTE (LJX) (2) ENZYME IMMUNOASSAY, AMPHETAMINE (DKZ) (1) ENZYME IMMUNOASSAY, BARBITURATE (DIS) (1) ENZYME IMMUNOASSAY, CANNABINOIDS (LDJ) (1) ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES (DIO) (1) ACID, ASCORBIC, 2,4-DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC) (JMA) (1) ENZYME IMMUNOASSAY, OPIATES (DJG) (1) Enzyme immunoassay, benzodiazepine (JXM) (1) Enzyme immunoassay, phencyclidine (LCM) (1) GAS CHROMATOGRAPHY, METHAMPHETAMINE (LAF) (1) NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) (JIN) (1) REFRACTOMETER FOR CLINICAL USE (JRE) (1) ENZYME IMMUNOASSAY, METHADONE (DJR) (1) AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) (JJB) (1) BLOOD, OCCULT, COLORIMETRIC, IN URINE (JIO) (1) DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) (CDM) (1) DYE-INDICATOR, PH (URINARY, NON-QUANT.) (CEN) (1)

Premarket Exempt

Clear

Detector UA 10 - 10722355002221 Catalog Number :

Device Description : Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which sever Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed

Device Class :

Duns Number: 119214195

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 100

Detector UA 5 - 10722355002238 Catalog Number :

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JIO, JIR, LJX, JMT, JIL

Prescription Use : Yes

Device Count : 100

Detector UA 2 - 10722355002245 Catalog Number :

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JIR, JIL

Prescription Use : Yes

Device Count : 100

hema-screen ER - 10722355002504 Catalog Number :

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

hema-screen ER - 10722355002511 Catalog Number :

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

hema-screen ER - 10722355002528 Catalog Number :

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

hema-screen ER - 10722355002535 Catalog Number :

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 34

hema-screen ER - 10722355002542 Catalog Number :

Device Description : Fecal Occult Blood IVD, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

hema-screen ER developer - 10722355002559 Catalog Number :

Device Description : Fecal Occult Blood Reagent, Guaiac

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 8

Detector Drug Cup - 10722355002566 Catalog Number :

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

Prescription Use : Yes

Device Count : 25

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