FDA.reportPublic FDA data

OraQuick HIV Self-Test

Primary DI
00608337001860
Brand
OraQuick HIV Self-Test
Company
Orasure Technologies, Inc.
Model
3001-3822UR2
Published
2026-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSSHiv Self-Tests

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSSHiv Self-TestsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP120001780

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP120001780

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608337001867PackageGS16In Commercial Distribution
00608337001860PrimaryGS10
00608337001853Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060833700186710608337001867
00608337001860006083370018606083370018600608337001860
00608337001853006083370018536083370018530608337001853

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antibody IVD, kit, rapid ICT, self-testingA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
610-882-1820customercare@orasure.com

Regulatory Flags#

DUNS number
114152184
Device count
2
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608337000115OraSure Oral Fluid Collection Device3001-28702019-02-15
00608337000559Histofreezer1001-03752016-09-15
00608337360103Histofreezer1001-02952016-09-15
00608337365108Histofreezer1001-02942016-09-15
00608337402100Histofreezer1001-02932016-09-15
20608337000065OraSure Quick Flu 22-Count Flu A + B Kit1001-03202016-11-10
00608337000047OraSure Quickflu Nasopharyngeal Wash / Aspirate1001-03212016-11-25
00608337000054OraSure QuickFlu Positive and Negative Control Kit1001-03232018-03-23
00608337001297Histofreezer1001-03362016-09-16
10608337001850OraQuick HIV Self-Test3001-3822U22026-05-08
00608337000078Intercept3001-28692016-07-29
00608337150308Q.E.D. Saliva Alcohol Test A150601562016-07-29
00608337000030Kit, MP Cotinine Serum 100 plate1124EC2021-01-22
00608337000023Methamphetamine Intercept 2 Plate Kit1104IT2016-09-12
00608337000085Auto-Lyte1224UM1224UM2016-04-29
00608337000146Amphetamine Intercept 5 Plate Kit1103IB2016-09-12
00608337000153Amphetamine Intercept 100 Plate Kit1103IC2016-09-12
00608337000184Methamphetamine Intercept 5 Plate Kit1104IB2016-09-12
00608337000191Methamphetamine Intercept 100 Plate Kit1104IC2016-09-12
00608337000207Barbiturates Intercept 5 Plate Kit1108IB2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10608337001850OraQuick HIV Self-TestOrasure Technologies, Inc.QSS2026-05-08
00686597201725INSTI HIV Self TestBiolytical Laboratories IncQSS2025-11-19