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
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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
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