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, RHEUMATOID FACTOR (DHR) (5) KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER (LCX) (2) AGGLUTINATION METHOD, HUMAN CHORIONIC GONADOTROPIN (JHJ) (1) SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS (KTN) (1) Visual, pregnancy hCG, prescription use (JHI) (1)

Premarket Exempt

Clear

Detector hCG Personal - 10722355001392 Catalog Number :

Device Description : For the qualitative detection of hCG in urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 100

Detector hCG - 10722355001415 Catalog Number :

Device Description : For the detection of hCG in urine to aid in the determination of pregnancy

Device Class : 2

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

Detector Cept-D Polyclonal - 10722355001446 Catalog Number :

Device Description : A rapid latex inhibition slide test for the detection of hCG in urine

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : JHJ

Prescription Use : Yes

Device Count : 100

Detector Personal - 10722355001453 Catalog Number :

Device Description : Home pregnancy test for early results

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 3

Detector Lex RA - 10722355001460 Catalog Number :

Device Description : A rapid undiluted latex slide test for the detection of rheumatoid factors

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 50

Detector Lex RA - 10722355001477 Catalog Number :

Device Description : A rapid undiluted latex slide test for the detection of rheumatoid factors

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 100

Detector Lex-IM - 10722355001491 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 : 25

Detector Rheumacol - 10722355001507 Catalog Number :

Device Description : A rapid color enhanced hemagglutination slide test for the detection of rheumato A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 50

Detector Rheumacol - 10722355001514 Catalog Number :

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 100

Detector Rheumacol Lex - 10722355001521 Catalog Number :

Device Description : A rapid color enhanced undiluted latex slide test for the qualitative or semi- q A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum

Device Class :

Duns Number: 119214195

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 50

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