FDA.reportPublic FDA data

BD Difco™ QC Antigen Shigella Group A

Primary DI
00382902210016
Brand
BD Difco™ QC Antigen Shigella Group A
Company
BECTON, DICKINSON AND COMPANY
Model
221001
Catalog number
221001
Device description
Vial Qc Antigen Shigella Grp A 1Ml
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
00382902210016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902210016003829022100163829022100160382902210016

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
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
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

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
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