FDA.reportPublic FDA data

BD Difco™ Neisseria Meningitidis Antiserum Group W135

Primary DI
00382902225317
Brand
BD Difco™ Neisseria Meningitidis Antiserum Group W135
Company
BECTON, DICKINSON AND COMPANY
Model
222531
Catalog number
222531
Device description
Vial N Meningitidis Antiserum Grp W135
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
GTJANTISERA, ALL GROUPS, N. MENINGITIDIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTJAntisera, All Groups, N. MeningitidisMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902225317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902225317003829022253173829022253170382902225317

GMDN Terms#

Term, Definition table
TermDefinition
Neisseria meningitidis 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 Neisseria meningitidis bacteria isolated by culture from a clinical specimen.

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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056080501567EDTA SolutionREMEL EUROPE LIMITEDGTJ2021-07-21
07350049850221Phadebact CSF TestMkl Diagnostics ABGTJ2016-11-17
05056080500973NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500980NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500997NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501130NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501147NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501154NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501161NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501178NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501185NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501192NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501208NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501215NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501222NAREMEL EUROPE LIMITEDGTJ2016-09-24
00382902555605BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test KitBECTON, DICKINSON AND COMPANYGTJ2016-07-07
30382902523506BD Directigen™ Meningitis Test Negative Control ReagentBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902523604BD Directigen™ Meningitis Combo Test KitBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902524809BD Directigen™ Meningitis Combo Test CardsBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902563914BD Directigen™ Specimen Buffer SolutionBECTON, DICKINSON AND COMPANYGTJ2016-05-19
00382902288114BD Difco™ Neisseria Meningitidis Antiserum Group YBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902289111BD Difco™ Neisseria Meningitidis Antiserum Group ZBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902291015BD Difco™ Neisseria Meningitidis Antiserum Poly 2 Contains Groups X, Y, ZBECTON, DICKINSON AND COMPANYGTJ2016-05-03
00382902225218BD Difco™ Neisseria Meningitidis Antiserum Group ZBECTON, DICKINSON AND COMPANYGTJ2016-04-29
00382902288015BD Difco™ Neisseria Meningitidis Antiserum Group XBECTON, DICKINSON AND COMPANYGTJ2016-04-29
00382902222811BD Difco™ Neisseria Meningitidis Antiserum Group ABECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902222910BD Difco™ Neisseria Meningitidis Antiserum Group BBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223016BD Difco™ Neisseria Meningitidis Antiserum Group CBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223115BD Difco™ Neisseria Meningitidis Antiserum Group DBECTON, DICKINSON AND COMPANYGTJ2016-04-28
00382902223214BD Difco™ Neisseria Meningitidis Antiserum Poly Contains Groups A, B, C, DBECTON, DICKINSON AND COMPANYGTJ2016-04-28