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) (4) ANTIGENS, NONTREPONEMAL, ALL (GMQ) (2) Helicobacter pylori (LYR) (2) Visual, pregnancy hCG, prescription use (JHI) (2)

Premarket Exempt

Clear

Detector RPR - 10722355001804 Catalog Number : RPR-5002C

Device Description : A macroscopic card test for the qualitative detection and semi-quantitative dete A macroscopic card test for the qualitative detection and semi-quantitative determination of syphilis in human plasma or serum

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 500

Detector RPR - 10722355001811 Catalog Number : RPR-5003C

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : GMQ

Prescription Use : Yes

Device Count : 500

hema-screen SPECIFIC - 10722355001835 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 : 200

Detector H. pylori - 10722355002016 Catalog Number :

Device Description : Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 10

Detector H. pylori - 10722355002023 Catalog Number :

Device Description : Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 30

Detector hCG Stick - 10722355002054 Catalog Number :

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

Detector hCG - 10722355002061 Catalog Number :

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

hema-screen Mailing Envelopes - 10722355002122 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 : 100

hema-screen 340 Test - 10722355002139 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 : 340

hema-screen Triple 335 - 10722355002146 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 : 335

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