FDA.reportPublic FDA data

BD Difco™ Salmonella H Antiserum Single Factor s

Primary DI
00382902255017
Brand
BD Difco™ Salmonella H Antiserum Single Factor s
Company
BECTON, DICKINSON AND COMPANY
Model
225501
Catalog number
225501
Device description
BD Difco™ Salmonella H Antiserum Single Factor s
Published
2016-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GRMANTISERA, ALL GROUPS, SALMONELLA SPP.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRMAntisera, All Groups, Salmonella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902255017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902255017003829022550173829022550170382902255017

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Salmonella 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 Salmonella 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904450106BD Veritor™ InfoWiFi Module4450104450102026-03-13
10382902212673BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2212672212672016-12-21
30382903836483Nexiva3836483836482026-02-17
30382903810124Insyte Autoguard3810123810122026-02-13
30382903810230Insyte Autoguard3810233810232026-02-13
30382903810247Insyte Autoguard3810243810242026-02-13
30382903810339Insyte Autoguard3810333810332026-02-13
30382903810346Insyte Autoguard3810343810342026-02-13
30382903810377Insyte Autoguard3810373810372026-02-13
30382903810445Insyte Autoguard3810443810442026-02-13
30382903810476Insyte Autoguard3810473810472026-02-13
50382903810548Insyte Autoguard3810543810542026-02-13
50382903810579Insyte Autoguard3810573810572026-02-13
30382903818335Insyte Autoguard3818333818332026-02-13
30382903818373Insyte Autoguard3818373818372026-02-13
50382903818476Insyte Autoguard3818473818472026-02-13
30382903818540Insyte Autoguard3818543818542026-02-13
50382903818575Insyte Autoguard3818573818572026-02-13
50382903818674Insyte Autoguard3818673818672026-02-13
30382903819127Insyte Autoguard3819123819122026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15060392375768Mast Assure AntiseraMAST GROUP LIMITEDGRM2022-04-05
15060392376178Mast Assure AntiseraMAST GROUP LIMITEDGRM2021-09-22
15060392375966Mast Assure AntiseraMAST GROUP LIMITEDGRM2021-08-05
05713106183496Salmonella Sero-Quick Group Kit, 8 x 3 mLSsi Diagnostica A/SGRM2021-07-25
05713106183502Salmonella Sero-Quick ID Kit, 8 x 3 mLSsi Diagnostica A/SGRM2021-07-25
05056080500775Salmonella H z Agglutinating SeraREMEL EUROPE LIMITEDGRM2021-07-21
15060392376116Mast Assure AntiseraMAST GROUP LIMITEDGRM2021-02-23
15060392376192Mast Assure AntiseraMAST GROUP LIMITEDGRM2021-02-01
00083059100754EZ-SALMONELLA One-Step Salmonella species Rapid TestBIOMERICA, INC.GRM2020-07-01
15060392376161Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-04-30
15060392376130Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-03-21
15060392375737Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-03-13
15060392375720Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-03-07
15060392375959Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-02-22
15060392375812Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-02-14
15060392375836Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-02-08
15060392376062Mast Assure AntiseraMAST GROUP LIMITEDGRM2019-01-21
15060392375805Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-12-13
15060392376086Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-12-12
15060392375867Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-11-23
15060392376048Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-11-23
15060392376079Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-11-19
15060392375904Mast AssureMAST GROUP LIMITEDGRM2018-10-10
15056152701557Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23
15060392375669Mast Assure antiseraMAST GROUP LIMITEDGRM2018-08-23
15060392375713Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23
15060392375881Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23
15060392375898Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23
15060392375911Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23
15060392376017Mast Assure AntiseraMAST GROUP LIMITEDGRM2018-08-23