FDA.reportPublic FDA data

BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit

Primary DI
00382902560418
Brand
BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit
Company
BECTON, DICKINSON AND COMPANY
Model
256041
Catalog number
256041
Device description
Kit Flu A+B 30 Test Hospital Veritor
Published
2017-02-02
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
GNXANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
PSZDevices detecting influenza A, B, and C virus antigens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, CMicrobiology1
PSZDevices Detecting Influenza A, B, And C Virus AntigensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120049000
K121797000
K132256000
K132693000
K133138000
K151301000
K152874000
K160164000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120049000BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2012-03-23PSZ
K121797000BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2012-09-07PSZ
K132256000BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+BBecton, Dickinson and Company2013-08-07PSZ
K132693000BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company2013-10-02PSZ
K133138000BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO2013-11-13PSZ
K151301000BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company2015-06-08PSZ
K152874000BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co.2015-10-27PSZ
K160164000BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO2016-02-25PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032902560417PackageGS112In Commercial Distribution
00382902560418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05032902560417050329025604175032902560417
00382902560418003829025604183829025604180382902560418

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 Temperature2 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
Kit
true
Lot or batch
true
Expiration date on label
true

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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
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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