OraQuick Advance Rapid HIV 1/2 Antibody Test

GUDID 20608337000010

Orasure Technologies, Inc.

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

• Primary Device ID: 20608337000010
• NIH Device Record Key: d6678785-c442-4d19-bfc7-a95495627ef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OraQuick Advance Rapid HIV 1/2 Antibody Test
• Version Model Number: 3001-1197
• 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: 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: 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 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608337000016 [Primary]
GS1	10608337000013 [Package]; Contains: 00608337000016; Package: Carton [100 Units]; In Commercial Distribution
GS1	20608337000010 [Package]; Contains: 00608337000016; Package: Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BP010047

FDA Product Code

• MTL: Monitor,Test,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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-05

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• 20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test: 2018-07-06