FDA.reportPublic FDA data

BD Directigen™ Meningitis Test Negative Control Reagent

Primary DI
30382902523506
Brand
BD Directigen™ Meningitis Test Negative Control Reagent
Company
BECTON, DICKINSON AND COMPANY
Model
252350
Catalog number
252350
Device description
BD Directigen™ Meningitis Test Negative Control Reagent
Published
2016-05-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
30382902523506PrimaryGS10
00382902523505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290252350630382902523506
00382902523505003829025235053829025235050382902523505

GMDN Terms#

Term, Definition table
TermDefinition
Multiple meningitis-associated bacteria 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 one or multiple bacteria associated with meningitis, in a clinical specimen. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume9Milliliter

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
4
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
00382902225317BD Difco™ Neisseria Meningitidis Antiserum Group W135BECTON, 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