BD Directigen™ H. influenzae type b Test Kit

Primary DI
00382902522607
Brand
BD Directigen™ H. influenzae type b Test Kit
Company
BECTON, DICKINSON AND COMPANY
Model
252260
Catalog number
252260
Device description
BD Directigen™ H. influenzae type b Test
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GRPANTISERA, ALL TYPES, H. INFLUENZA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRPAntisera, All Types, H. InfluenzaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902522607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902522607003829025226073829025226070382902522607

GMDN Terms#

Term, Definition table
TermDefinition
Multiple meningitis-associated bacteria antigen IVD, kit, agglutinationA collection of reagents and other associated materials 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, using an agglutination method. Bacteria detected may include Haemophilus influenzae, Streptococcus pneumoniae, Neisseria meningitidis, Group B streptococcus or Escherichia coli (E. coli) bacteria.

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

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00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
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00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15060392377601Mast Assure AntiseraMAST GROUP LIMITEDGRP2022-04-06
15060392376338Mast Assure AntiseraMAST GROUP LIMITEDGRP2021-09-22
04048474025309Haemophilus influenza B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRP2019-06-06
00404847425307Haemophilus influenza B IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungGRP2019-06-06
15060392377564Mast Assure AntiseraMAST GROUP LIMITEDGRP2018-12-12
15060392377571Mast Assure AntiseraMAST GROUP LIMITEDGRP2018-08-17
07350049850115Phadebact Haemophilus TestMkl Diagnostics ABGRP2016-11-17
05051700006767VaccZyme™ Human Anti-Haemophilus Influenzae type b Enzyme Immunoassay KitTHE BINDING SITE GROUP LIMITEDGRP2016-09-24
05056080501079NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501086NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501093NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501109NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501116NAREMEL EUROPE LIMITEDGRP2016-09-24
05056080501123NAREMEL EUROPE LIMITEDGRP2016-09-24
05713106034620H. influenzae Type b serum, 1 mLSsi Diagnostica A/SGRP2016-09-13
05713106852057ImmuLex H. influenzae type b antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914601ImmuLex H. influenzae type a antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914618ImmuLex H. influenzae type c antiserum, 1,5 mLSsi Diagnostica A/SGRP2016-09-13
05713106914625ImmuLex H. influenzae type d antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914649ImmuLex H. influenzae type e antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914656ImmuLex H. influenzae type f antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
05713106914670ImmuLex H. influenzae polyv. Antiserum, 1,5mLSsi Diagnostica A/SGRP2016-09-13
00382902223719BD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, fBECTON, DICKINSON AND COMPANYGRP2016-07-07
00382902278917BD Difco™ Haemophilus influenzae Antiserum Type cBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279013BD Difco™ Haemophilus influenzae Antiserum Type dBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279112BD Difco™ Haemophilus Influenzae Antiserum Type eBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902279211BD Difco™ Haemophilus Influenzae Antiserum Type fBECTON, DICKINSON AND COMPANYGRP2016-04-29
00382902223610BD Difco™ Haemophilus Influenzae Antiserum Type bBECTON, DICKINSON AND COMPANYGRP2016-04-28
00382902225010BD Difco™ Haemophilus Influenzae Antiserum Type aBECTON, DICKINSON AND COMPANYGRP2016-04-28