Bio-Rad Laboratories, Inc. 25179

GUDID 00847865010740

HSV IgG EIA

Bio-RAD Laboratories, Inc.

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

• Primary Device ID: 00847865010740
• NIH Device Record Key: fd6c75fb-35c5-4a6f-8363-786c7f2cfdcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Rad Laboratories, Inc.
• Version Model Number: 25179
• Catalog Number: 25179
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: TechSupport.USSD-Redmond@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865010740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963282

FDA Product Code

• LGC: Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [Bio-Rad Laboratories, Inc.]

• 00847865019354: Slide Blotters, 24-well
• 00847865019347: Slide Blotters, 8-well
• 00847865019330: Slide Blotters, 4-well
• 00847865017343: Slide Blotters, 6-well
• 00847865017244: Slide Blotters, 12-well
• 00847865011495: Anti-Borrelia (Lyme) EIA, Conjugate
• 00847865011488: Anti-Borrelia (Lyme) EIA, Borrelia Blocker
• 00847865011471: Anti-Borrelia (Lyme) EIA, Positive Control
• 00847865011464: Anti-Borrelia (Lyme) EIA, Negative Control
• 00847865011457: Anti-Borrelia (Lyme) EIA Calibrator
• 00847865011280: Anti-Borrelia (Lyme) EIA, Stop Solution
• 00847865011273: Anti-Borrelia (Lyme) EIA , Substrate Concentrate
• 00847865011266: Anti-Borrelia (Lyme) EIA, Substrate Buffer
• 00847865011259: Anti-Borrelia (Lyme) EIA, Wash Buffer Concentrate [20X]
• 00847865011198: Substrate for Serology EIA Tests
• 00847865011181: Stop Reagent for Serology EIA Tests
• 00847865011174: Wash Concentrate for Serology EIA Tests
• 00847865011150: Diluent for Rubella IgM, CMV IgM and VCA IgM EIA Tests
• 00847865011136: Diluent for Rubella, Toxo, CMV, HSV, VZV, Measles, Mumps, EBNA and EB EAD IgG EIA Tests
• 00847865010757: VZV IgG EIA
• 00847865010740: HSV IgG EIA
• 00847865010733: CMV IgM EIA
• 00847865010726: CMV IgG EIA
• 00847865010702: Toxoplasma IgG EIA
• 00847865010696: Rubella IgM EIA
• 00847865010689: Rubella IgG EIA
• 00847865001731: PBS For Immunofluorescent Assays, 11.34 gm
• 00847865001274: Anti-Borrelia (Lyme) Microplate EIA