Bio-Rad 25228

GUDID 00847865002745

MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests

Bio-RAD Laboratories, Inc.

HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00847865002745
• NIH Device Record Key: 231c23fd-51d4-44b3-b206-8c7140130e7c
• Commercial Distribution Discontinuation: 2017-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bio-Rad
• Version Model Number: 25228
• Catalog Number: 25228
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865002745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP040046

FDA Product Code

• MZF: Test, Hiv Detection

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: 2018-07-06
• Device Publish Date: 2014-08-22

On-Brand Devices [Bio-Rad ]

• 00847865018456: MULTISPOT HIV-1/HIV-2 Rapid Test Negative Control Serum (Human) 1.0 mL
• 00847865002745: MULTISPOT HIV-1/HIV-2 Rapid Test 50 Tests
• 00847865001816: Chromogen:TMB Solution 1:11 12 mL
• 00847865001809: Substrate Buffer TMB buf., 120 mL
• 00847865001793: STOP Stopping Solution 1N 15 x 120 mL
• 00847865001786: Wash Solution Concentrate (30X), 15 x 120 mL
• 03610522051236: HSV Type 2 Specific IgG EIA Test Set
• 03610522051076: HSV Type 1 Specific IgG EIA Test Set