ReQuest 01550Q-1

GUDID 00850487007159

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

QUEST INTERNATIONAL, INC.

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850487007159
• NIH Device Record Key: e829ba4e-eae7-42d0-ab69-21506e97c286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReQuest
• Version Model Number: H.pylori G
• Catalog Number: 01550Q-1
• Company DUNS: 883350811
• Company Name: QUEST INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850487007159 [Primary]

FDA Product Code

• LYR: Helicobacter Pylori

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-31

On-Brand Devices [ReQuest ]

• 00850487007647: Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007623: Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
• 00850487007302: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
• 00850487007296: Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007289: Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
• 00850487007272: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
• 00850487007265: Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
• 00850487007258: SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
• 00850487007241: Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007234: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)
• 00850487007227: Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007210: Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007203: Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007197: Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme imm
• 00850487007180: Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007173: Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007166: Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immun
• 00850487007159: Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007142: Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoass
• 00850487007135: Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007128: Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007111: Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007104: Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007098: Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007081: Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007074: Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007067: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007050: Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007043: Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007036: Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007029: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007012: Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
• 00850487007005: SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)