GS 25104

GUDID 00847865001861

HBsAg EIA 3.0 Conjugate Diluent, 120 mL

Bio-RAD Laboratories, Inc.

Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00847865001861
• NIH Device Record Key: 13a67d09-b947-407d-86bb-8395aa8f40d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GS
• Version Model Number: 25104
• Catalog Number: 25104
• 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: false
• 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
• 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

• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter
• Total Volume: 120 Milliliter

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
• 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	00847865001861 [Primary]

FDA Product Code

• LOM: Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-23
• Device Publish Date: 2014-08-22

On-Brand Devices [GS]

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• 00847865013246: GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 40 mL
• 00847865013239: GS HIV Combo Ag/Ab EIA, Conjugate 2, Lyophilized, 18 mL
• 00847865013222: GS HIV Combo Ag/Ab EIA, Conjugate 1, 10 mL
• 00847865013215: GS HIV Combo Ag/Ab EIA, Cutoff Calibrator, 1.7 mL
• 00847865013208: GS HIV Combo Ag/Ab EIA, HIV-2/O Ab Pos Ctrl, 1.5 mL
• 00847865013192: GS HIV Combo Ag/Ab EIA, HIV-1 Ab Pos Ctrl, 1.5 mL
• 00847865013185: GS HIV Combo Ag/Ab EIA, Negative Control, 1.5 mL
• 00847865011563: Human Immunodeficiency Virus Type 2, GS HIV-2 EIA, 480-Test Kit
• 00847865010672: GS HIV Combo Ag/Ab EIA, HIV Ag Pos Ctrl, 1.5 mL
• 00847865010665: GS HIV Combo Ag/Ab EIA, 960 Tests
• 00847865010658: GS HIV Combo Ag/Ab EIA, 192 Tests
• 00847865003063: HIV-1 Western Blot, Strip Folder 10/pkg
• 00847865003056: HIV-1 Western Blot, Strip Worksheet 50/pkg
• 00847865003049: Human Immunodeficiency Virus Type 1 GS HIV-1 Western Blot, (40 Tests)
• 00847865002752: HIV-1 Western Blot, Specimen Diluent/Wash (5X), 100 mL
• 00847865002028: HIV-1/HIV-2 PLUS O EIA Specimen Diluent, 100 mL
• 00847865002011: HIV-1/HIV-2 PLUS O EIA Conjugate Concentrate, 12 mL
• 00847865002004: HIV-1/HIV-2 PLUS O EIA Conjugate Diluent, 120 mL
• 00847865001991: HIV-1/HIV-2 PLUS O EIA HIV-1 Group O Positive Control, 1.4 mL
• 00847865001984: HIV-1/HIV-2 PLUS O EIA HIV-2 Positive Control, 1.4 mL
• 00847865001977: HIV-1/HIV-2 PLUS O EIA HIV-1 Positive Control, 1.4 mL
• 00847865001960: HIV-1/HIV-2 PLUS O EIA HIV Negative Control, 8 mL
• 00847865001953: Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 P
• 00847865001946: Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL
• 00847865001939: Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptide) GS HIV-1/HIV-2 PL
• 00847865001922: Antibody to Hepatitis B Surface Antigen (Human) GS HBsAg 3.0 - HBsAg Confirmatory Assay 3.0
• 00847865001892: HBsAg EIA 3.0 Low Positive Control, 8 mL
• 00847865001885: HBsAg EIA 3.0 Positive Control, 8 mL
• 00847865001878: HBsAg EIA 3.0 Negative Control, 12 mL
• 00847865001861: HBsAg EIA 3.0 Conjugate Diluent, 120 mL
• 00847865001854: HBsAg EIA 3.0 Conjugate Concentrate, 1.2 mL
• 00847865001847: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 4800 Tests
• 00847865001830: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 960 Tests
• 00847865001823: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) GS HBsAg EIA 3.0 480 Tests
• 03610522112777: GS HIV Combo Ag/Ab EIA, 192 Tests
• 03610522112791: GS HIV Combo Ag/Ab EIA, 4800 Tests
• 03610522112784: GS HIV Combo Ag/Ab, 960 Tests
• 03610522110414: Conjugate 2 Diluent, GS HIV Combo Ag/Ab, 120mL
• 03610522110209: Conjugate 2, GS HIV Combo Ag/Ab, 12 mL
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• 03610520505304: Western Blot Trays & Lids 8/pkg