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

SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS (KTN) (8) SYSTEM, TEST, C-REACTIVE PROTEIN (DCN) (2)

Premarket Exempt

Clear

Detector Lex-CRP - 10722355001187 Catalog Number :

Device Description : A rapid undiluted 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 Lex-CRP - 10722355001194 Catalog Number :

Device Description : A rapid undiluted 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

Detector Color IM - 10722355001200 Catalog Number :

Device Description : A simple color enhanced slide test for the detection of infectious mononucleosis

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 50

Detector Color IM - 10722355001217 Catalog Number :

Device Description : A simple color enhanced slide test for the detection of infectious mononucleosis

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 100

Detector Monocol - 10722355001224 Catalog Number :

Device Description : A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 50

Detector Monocol - 10722355001231 Catalog Number :

Device Description : A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 100

Detector Lex-IM - 10722355001248 Catalog Number :

Device Description : A rapid latex agglutination slide test for the detection of heterophile antibodi A rapid 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 : 50

Detector Mono - 10722355001255 Catalog Number :

Device Description : A qualitative immunoassay for the detection of infectious mononucleosis heteroph A qualitative immunoassay for the detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 25

Detector Lex-IM - 10722355001262 Catalog Number :

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 100

Detector Monocol Lex - 10722355001279 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 : 50

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