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, Cytomegalovirus (LFZ) (2) Epstein-Barr Virus, Other (LSE) (2) Antinuclear Antibody, Antigen, Control (LKJ) (1) Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB) (1) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (1)

Premarket Exempt

Yes No

Clear

ReQuest - 00850487007302 Catalog Number : Q01-310H

Device Description : Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LKJ

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007319 Catalog Number : Q01-140

Device Description : Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoa Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LFZ

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007326 Catalog Number : Q01-150

Device Description : Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LFZ

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007333 Catalog Number : Q01-160

Device Description : Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LGC

Prescription Use : Yes

Device Count : 1

SeraQuest - 00850487007340 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

SeraQuest - 00850487007357 Catalog Number : Q01-190

Device Description : Measles virus immunoglobulin G (IgG) 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 - 00850487007364 Catalog Number : Q01-460

Device Description : Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, k Epstein-Barr virus nuclear antigen (EBNA) 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 - 00850487007371 Catalog Number : Q01-470

Device Description : Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme im Epstein-Barr virus (EBV) VCA 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 - 00850487007388 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

SeraQuest - 00850487007395 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

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