FDA.reportPublic FDA data

OraSure HIV-1 Western Blot Kit

Primary DI
00608337000863
Brand
OraSure HIV-1 Western Blot Kit
Company
Orasure Technologies, Inc.
Model
501-0000
Published
2014-09-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVZSystem,Test,Home,Hiv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVZSystem, Test, Home, Hiv-1Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BP950004001
BP950004002
BP950004003
BP950004005
BP950004007
BP950004011
BP950004013

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP950004001
BP950004002
BP950004003
BP950004005
BP950004007
BP950004011
BP950004013

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00608337000863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608337000863006083370008636083370008630608337000863

GMDN Terms#

Term, Definition table
TermDefinition
HIV1 antibody IVD, kit, immunoblotA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
114152184
Device count
1
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
00608337001860OraQuick HIV Self-Test3001-3822UR22026-05-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M769HIVSTANDARD211HIV-1 Standard Test SystemHome Access Health CorporationMVZ2015-09-03
M769HIVEXPRESS201Express HIV-1 Test SystemHome Access Health CorporationMVZ2015-09-03
00608337000108OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.MVZ2014-09-05
20608337000102OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.MVZ2014-09-05