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, Mumps Virus (LJY) (2) Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB) (1) Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (MXJ) (1) Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (MYF) (1) Epstein-Barr Virus, Other (LSE) (1) Helicobacter Pylori (LYR) (1) System, Test, Anticardiolipin Immunological (MID) (1) Anti-Sm Antibody, Antigen And Control (LKP) (1) System, Test, Thyroid Autoantibody (JZO) (1)

Premarket Exempt

No Yes

Clear

SeraQuest - 00850487007500 Catalog Number :

Device Description : Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immu Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : JZO

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007517 Catalog Number :

Device Description : Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007524 Catalog Number : Q01-490

Device Description : Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 1

Duns Number: 883350811

Premarket Exempt : No

Product Code : LSE

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007531 Catalog Number : 01550Q-1

Device Description : Helicobacter pylori immunoglobulin G (IgG) 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 - 00850487007548 Catalog Number : 01-410

Device Description : Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme i Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : MXJ

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007555 Catalog Number : Q01-420

Device Description : Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme i Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : MYF

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007562 Catalog Number : Q01-190M

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

Device Class : 1

Duns Number: 883350811

Premarket Exempt : Yes

Product Code : LJB

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007579 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

SeraQuest - 00850487007586 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 : No

Product Code : LJY

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007593 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

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