FDA.reportPublic FDA data

BD Veritor™ Plus CLIA-Waived Combo Pack

Primary DI
00382902560746
Brand
BD Veritor™ Plus CLIA-Waived Combo Pack
Company
BECTON, DICKINSON AND COMPANY
Model
256074
Catalog number
256074
Device description
Combo Veritor Plus CLIA- Waived Flu Kit
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GNXANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
GTYANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1
GTYAntigens, All Groups, Streptococcus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112277000BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2011-10-28PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902560746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902560746003829025607463829025607460382902560746

GMDN Terms#

Term, Definition table
TermDefinition
Influenza/parainfluenza virus antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from influenza and parainfluenza viruses [e.g., influenza A, influenza B, human parainfluenza virus 1 (HPIV-1), human parainfluenza virus 2 (HPIV-2)] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

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