OraSure HIV-1 Oral Specimen Collection Device

Primary DI
00608337000108
Brand
OraSure HIV-1 Oral Specimen Collection Device
Company
Orasure Technologies, Inc.
Model
HIV-1 Oral Specimen Collection Device
Published
2014-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
BP910001002
BP910001004
BP910001006
BP910001008
BP910001010
BP910001016
BP910001017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BP910001002
BP910001004
BP910001006
BP910001008
BP910001010
BP910001016
BP910001017

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608337000105PackageGS150In Commercial Distribution
20608337000102PackageGS1500In Commercial Distribution
00608337000108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060833700010510608337000105
2060833700010220608337000102
00608337000108006083370001086083370001080608337000108

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
114152184
Device count
1
DM exempt
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
20608337000102OraSure HIV-1 Oral Specimen Collection DeviceOrasure Technologies, Inc.MVZ2014-09-05
00608337000863OraSure HIV-1 Western Blot KitOrasure Technologies, Inc.MVZ2014-09-05