QUEST INTERNATIONAL, INC.

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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

Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (2) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (2) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) System, Test, Anticardiolipin Immunological (MID) (1) System, Test, Thyroid Autoantibody (JZO) (1) Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM) (1) Thyroglobulin, Antigen, Antiserum, Control (DDC) (1) Anti-Sm Antibody, Antigen And Control (LKP) (1)

Premarket Exempt

No Yes

Clear

ReQuest - 00850487007203 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

ReQuest - 00850487007210 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

ReQuest - 00850487007227 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

ReQuest - 00850487007234 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

ReQuest - 00850487007241 Catalog Number : 1

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

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : DDC

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007258 Catalog Number : Q01-260

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

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007265 Catalog Number : Q01-230

Device Description : Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LKP

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007272 Catalog Number : 01-270

Device Description : Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007289 Catalog Number :

Device Description : Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LRM

Prescription Use : Yes

Device Count : 1

ReQuest - 00850487007296 Catalog Number : 01-280

Device Description : Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)

Device Class : 2

Duns Number: 883350811

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

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