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

Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (2) Enzyme Linked Immunoabsorbent Assay, Mumps Virus (LJY) (2) Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (2) Anti-Sm Antibody, Antigen And Control (LKP) (1) Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (LIP) (1) Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (1) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1)

Premarket Exempt

No Yes

Clear

ReQuest - 00850487007005 Catalog Number : Q01-250

Device Description : SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007012 Catalog Number : Q01-180

Device Description : Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme im Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LFY

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007029 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 - 00850487007036 Catalog Number : Q01-120

Device Description : Toxoplasma gondii immunoglobulin G (IgG) 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 - 00850487007043 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

ReQuest - 00850487007050 Catalog Number : Q01-240

Device Description : Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LKP

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007067 Catalog Number : Q01-110

Device Description : Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LFX

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007074 Catalog Number : Q01-100

Device Description : Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LFX

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007081 Catalog Number : Q01-200M

Device Description : Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 1

Duns Number: 883350811

Premarket Exempt : Yes

Product Code : LJY

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007098 Catalog Number : Q01-200

Device Description : Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 1

Duns Number: 883350811

Premarket Exempt : No

Product Code : LJY

Prescription Use : Yes

Device Count : 1

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