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

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30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
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00382904003722BD Whitacre Spinal4003724003722023-09-02
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