FDA.reportPublic FDA data

BD Difco™ QC Antigen Shigella Group B

Primary DI
00382902117384
Brand
BD Difco™ QC Antigen Shigella Group B
Company
BECTON, DICKINSON AND COMPANY
Model
211738
Catalog number
211738
Device description
BD Difco™ QC Antigen Shigella Group B
Published
2016-07-07
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
00382902117384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902117384003829021173843829021173840382902117384

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Shigella species culture isolate antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from one or multiple species of Shigella bacteria isolated by culture from a clinical specimen.

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
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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
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
00382902211617BD Difco™ QC Antigen Alkalescens Dispar Group 1BECTON, DICKINSON AND COMPANYLIA2016-04-28