BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

OraQuick HIV Self-Test

DI: 00608337001792 · Model: 3001-3822UR · Orasure Technologies, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: OraQuick HIV Self-Test
Primary DI: 00608337001792
Version / Model: 3001-3822UR
Company Name: Orasure Technologies, Inc.
Labeler DUNS: 114152184
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-09-05
Public Version: 1
Public Version Date: 2024-09-13
Public Version Status: New
Public Device Record Key: e4a6ef1d-c52d-4cc9-a084-b9c1745e0ba6

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
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
MZF	Test, Hiv Detection	Microbiology	866.3956	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65848	HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testing	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10608337001799	GS1	Shipper Box	24	In Commercial Distribution
Primary	00608337001792	GS1
Package	20608337001796	GS1	Shipper Box	6	In Commercial Distribution

Customer Contacts

Phone: 610-882-1820
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BP120001	714

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 2 – 27 Degrees Celsius