FDA.reportPublic FDA data

OraSure Quickflu Nasopharyngeal Wash / Aspirate

Primary DI
00608337000047
Brand
OraSure Quickflu Nasopharyngeal Wash / Aspirate
Company
Orasure Technologies, Inc.
Model
1001-0321
Published
2016-11-25
Public version status
Update
Distribution status
Not 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
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083746000BIOSIGN FLU A+BPrinceton BioMeditech Corp.2010-11-10PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00608337000047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608337000047006083370000476083370000470608337000047

GMDN Terms#

Term, Definition table
TermDefinition
Influenza A/B virus antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 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
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
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
00608337000207Barbiturates Intercept 5 Plate Kit1108IB2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16977977230024N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
16977977230031N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
26977977230021N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
26977977230038N/AZhengzhou Shiyi Biotech Co., Ltd.GNX2025-01-28
05032384502981IMAGEN Influenza Virus A and BOXOID LIMITEDGNX2024-12-30
00855113008722ClearFitLONGEVITI NEURO SOLUTIONS LLCGNX2024-03-20
00855113008661Longeviti Convenience Kit 5.0LONGEVITI NEURO SOLUTIONS LLCGNX2024-03-15
08033891327514CHORUS INFLUENZA A IgGDIESSE DIAGNOSTICA SENESE SPAGNX2024-01-22
08033891327538CHORUS INFLUENZA B IgGDIESSE DIAGNOSTICA SENESE SPAGNX2024-01-22
00848838063701Remel REMEL, INC.GNX2021-11-12
30848838063702Remel REMEL, INC.GNX2021-11-12
03848838063708Remel REMEL, INC.GNX2021-11-12
00816917022925Poly statPOLYMEDCO, INC.GNX2019-04-18
30014613331469QuickVueQUIDEL CORPORATIONGNX2019-04-17
30014613003175QuickVueQUIDEL CORPORATIONGNX2019-03-21
30014613201830QuickVueQUIDEL CORPORATIONGNX2018-11-10
30014613202189SofiaQUIDEL CORPORATIONGNX2018-11-10
30014613202547SofiaQUIDEL CORPORATIONGNX2018-11-10
10743816001508Status Flu A+B cardPRINCETON BIOMEDITECH CORPORATIONGNX2018-07-05
00382902560708BD Veritor™ Plus Laboratory Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
00382902560739BD Veritor™ System Laboratory Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
00382902560746BD Veritor™ Plus CLIA-Waived Combo PackBECTON, DICKINSON AND COMPANYGNX2018-05-25
10743816001478BioSign Flu A+B cardPRINCETON BIOMEDITECH CORPORATIONGNX2018-04-09
10743816001447Status Flu A & BPRINCETON BIOMEDITECH CORPORATIONGNX2017-10-13
20612479225118McKessonMCKESSON MEDICAL-SURGICAL INC.GNX2017-09-29
20612479226795McKessonMCKESSON MEDICAL-SURGICAL INC.GNX2017-09-29
10743816001430Status Flu A+B Validation KitPRINCETON BIOMEDITECH CORPORATIONGNX2017-05-10
10743816001416Status Flu A+B Nasal Wash/Aspirate KitPRINCETON BIOMEDITECH CORPORATIONGNX2017-04-20
00382902560418BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kitBECTON, DICKINSON AND COMPANYGNX2017-02-02
00382902560456BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kitBECTON, DICKINSON AND COMPANYGNX2017-02-02