FDA.reportPublic FDA data

BD Difco™ QC Antigen Alkalescens Dispar Group 1

Primary DI
00382902211617
Brand
BD Difco™ QC Antigen Alkalescens Dispar Group 1
Company
BECTON, DICKINSON AND COMPANY
Model
221161
Catalog number
221161
Device description
BD Difco™ QC Antigen Alkalescens Dispar Group 1
Published
2016-04-28
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
LIAANTIGENS, ALL GROUPS, SHIGELLA SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIAAntigens, All Groups, Shigella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902211617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902211617003829022116173829022116170382902211617

GMDN Terms#

Term, Definition table
TermDefinition
Escherichia coli antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli (E. coli) bacteria in a clinical specimen and/or culture isolate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382902117377BD Difco™ QC Antigen Shigella Group A1BECTON, DICKINSON AND COMPANYLIA2016-07-07
00382902117384BD Difco™ QC Antigen Shigella Group BBECTON, DICKINSON AND COMPANYLIA2016-07-07
00382902210016BD Difco™ QC Antigen Shigella Group ABECTON, DICKINSON AND COMPANYLIA2016-04-28
00382902210313BD Difco™ QC Antigen Shigella Group CBECTON, DICKINSON AND COMPANYLIA2016-04-28
00382902210412BD Difco™ QC Antigen Shigella Group C1BECTON, DICKINSON AND COMPANYLIA2016-04-28
00382902210511BD Difco™ QC Antigen Shigella Group C2BECTON, DICKINSON AND COMPANYLIA2016-04-28
00382902210610BD Difco™ QC Antigen Shigella Group DBECTON, DICKINSON AND COMPANYLIA2016-04-28