OraSure HIV-1 Western Blot Kit

Basic Information

• Brand Name: OraSure HIV-1 Western Blot Kit
• Primary DI: 00608337000863
• Version / Model: 501-0000
• Company Name: Orasure Technologies, Inc.
• Labeler DUNS: 114152184
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-05
• Public Version: 4
• Public Version Date: 2018-09-14
• Public Version Status: Update
• Public Device Record Key: e226451e-63c4-4290-9b3a-05bee4d103c6
• Distribution End Date: 2018-08-31

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
MVZ	System,Test,Home,Hiv-1	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48482	HIV1 antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the human immunodeficiency virus 1 (HIV1) in a clinical specimen, using an immunoblot assay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00608337000863	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
BP950004	001
BP950004	002
BP950004	003
BP950004	005
BP950004	007
BP950004	011
BP950004	013

Storage Conditions

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