OraQuick HCV Rapid Antibody Test Kit Controls

GUDID 00608337000542

Orasure Technologies, Inc.

Hepatitis C virus antibody/antigen IVD, control

• Primary Device ID: 00608337000542
• NIH Device Record Key: b3c9ccd1-3e18-4c1f-be5c-239d90483314
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OraQuick HCV Rapid Antibody Test Kit Controls
• Version Model Number: 1001-0182
• 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
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• Phone: 610-882-1820
• Email: customercare@orasure.com
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608337000542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080027

FDA Product Code

• MZO: Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus

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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• 20608337000065 - OraSure Quick Flu 22-Count Flu A + B Kit: 2018-07-06
• 00608337000009 - OraQuick Advance HIV 1/2 Kit Controls: 2018-07-06
• 20608337000010 - OraQuick Advance Rapid HIV 1/2 Antibody Test: 2018-07-06