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

Visual, pregnancy hCG, prescription use (JHI) (9) SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS (KTN) (1)

Premarket Exempt

Clear

Detector Monocol Lex - 10722355001286 Catalog Number :

Device Description : A rapid color enhanced latex agglutination slide test for the detection of heter A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 100

Detector hCG - 10722355001293 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 : 100

Detector hCG - 10722355001309 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 - 10722355001316 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 : 50

Detector hCG Stick - 10722355001330 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 Stick - 10722355001347 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 : 50

Detector hCG Stick - 10722355001354 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 : 100

Detector hCG Combi - 10722355001361 Catalog Number :

Device Description : For the qualitative detection of hCG in serum or urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Detector hCG Combi - 10722355001378 Catalog Number :

Device Description : For the qualitative detection of hCG in serum or urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 50

Detector hCG Combi - 10722355001385 Catalog Number :

Device Description : For the qualitative detection of hCG in serum or urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 100

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