OraQuick HCV Rapid Antibody Test Kit Controls

Basic Information

• Brand Name: OraQuick HCV Rapid Antibody Test Kit Controls
• Primary DI: 00608337000542
• Version / Model: 1001-0182
• Company Name: Orasure Technologies, Inc.
• Labeler DUNS: 114152184
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-05
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: b3c9ccd1-3e18-4c1f-be5c-239d90483314

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MZO	Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
48384	Hepatitis C virus antibody/antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus antigens and antibodies to Hepatitis C virus antigens in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00608337000542	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P080027	001
P080027	003
P080027	005
P080027	006
P080027	007
P080027	008
P080027	009
P080027	010
P080027	011
P080027	012
P080027	013
P080027	014
P080027	015
P080027	016
P080027	017

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius