QUEST INTERNATIONAL, 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

Extractable Antinuclear Antibody, Antigen And Control (LLL) (2) Helicobacter Pylori (LYR) (2) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (1) Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (LIP) (1)

Premarket Exempt

No Yes

Clear

SeraQuest - 00850487007609 Catalog Number : Q01-580

Device Description : Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LIP

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007616 Catalog Number : Q01-130

Device Description : Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LGD

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007623 Catalog Number : 01-330

Device Description : Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007630 Catalog Number : 01-330

Device Description : Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007647 Catalog Number :

Device Description : Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 1

Duns Number: 883350811

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007654 Catalog Number :

Device Description : Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 1

Duns Number: 883350811

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 1

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