OraSure HIV-1 Western Blot Kit

GUDID 00608337000863

Orasure Technologies, Inc.

HIV1 antibody IVD, kit, immunoblot

• Primary Device ID: 00608337000863
• NIH Device Record Key: e226451e-63c4-4290-9b3a-05bee4d103c6
• Commercial Distribution Discontinuation: 2018-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: OraSure HIV-1 Western Blot Kit
• Version Model Number: 501-0000
• Company DUNS: 114152184
• Company Name: Orasure Technologies, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608337000863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP950004

FDA Product Code

• MVZ: System,Test,Home,Hiv-1

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: 2018-09-14
• Device Publish Date: 2014-09-05

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