IMMUNOSTICS COMPANY, INC

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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

REAGENT, OCCULT BLOOD (KHE) (8) SYSTEM, TEST, C-REACTIVE PROTEIN (DCN) (2)

Premarket Exempt

Clear

hema-screen STAT - 10722355001057 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 SPECIFIC - 10722355001071 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 25

hema-screen SPECIFIC - 10722355001088 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 10

hema-screen SPECIFIC - 10722355001095 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 25

hema-screen SPECIFIC - 10722355001101 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 20

hema-screen SPECIFIC - 10722355001118 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 125

hema-screen - 10722355001125 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

hema-screen SPECIFIC - 10722355001156 Catalog Number :

Device Description : Immunological Fecal Occult Blood test

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 25

Detector C-Reactacol - 10722355001163 Catalog Number :

Device Description : A rapid color enhanced latex slide test for the detection of C-Reactive Protein

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 50

Detector C-Reactacol - 10722355001170 Catalog Number :

Device Description : A rapid color enhanced latex slide test for the detection of C-Reactive Protein

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 100

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