FDA.reportPublic FDA data

BD Difco™ Shigella Antiserum Poly Group B S. flexneri Serotypes 1–6

Primary DI
00382902283515
Brand
BD Difco™ Shigella Antiserum Poly Group B S. flexneri Serotypes 1–6
Company
BECTON, DICKINSON AND COMPANY
Model
228351
Catalog number
228351
Device description
BD Difco™ Shigella Antiserum Poly Group B S. flexneri Serotypes 1–6
Published
2016-04-29
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
GNBANTISERA, ALL TYPES, SHIGELLA SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GNBAntisera, All Types, Shigella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902283515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902283515003829022835153829022835150382902283515

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Shigella species culture isolate antigen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative 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 Volume3Milliliter

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
00382905167065BD Intelliport5167065167062020-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumREMEL EUROPE LIMITEDGNB2026-05-05
15060392377762Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377786Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377793Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377892Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377946Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377953Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377960Mast Assure Antisera MAST GROUP LIMITEDGNB2024-01-09
15060392377984Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
15060392377991Mast Assure AntiseraMAST GROUP LIMITEDGNB2024-01-09
05060472462718Polyvalent Shigella Slide Antisera - sonnei Phase 1 & 2PRO-LAB, INCORPORATEDGNB2022-12-20
05060472462725Polyvalent Shigella Slide Antisera - flexneri 1-6 X & YPRO-LAB, INCORPORATEDGNB2022-12-20
05060472462732Polyvalent Shigella Slide Antisera - dysenteriae 1-10PRO-LAB, INCORPORATEDGNB2022-12-20
05060472462749Polyvalent Shigella Slide Antisera - boydii 1-15PRO-LAB, INCORPORATEDGNB2022-12-20
15060392377854Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377878Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377885Mastr AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377908Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392377922Mast AssreMAST GROUP LIMITEDGNB2022-01-05
15060392377939Mast AssureMAST GROUP LIMITEDGNB2022-01-05
15060392376390Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-10-15
15060392377861Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-10-15
15060392377717Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-08-05
15060392377700Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377724Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377731Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377748Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392377755Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-16
15060392376345Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-07
15060392377694Mast Assure AntiseraMAST GROUP LIMITEDGNB2021-06-07