BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135

Primary DI
00382902501602
Brand
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Company
BECTON, DICKINSON AND COMPANY
Model
250160
Catalog number
250160
Device description
BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
Published
2016-07-07
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
GTIANTISERA, FLUORESCENT, ALL GROUPS, N. MENINGITIDIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTIAntisera, Fluorescent, All Groups, N. MeningitidisMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K920274000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K920274000DIRECTIGEN NEISSERIA MENINGITIDIS TESTBd Becton Dickinson Vacutainer Systems Preanalytic1992-03-18GTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902501602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902501602003829025016023829025016020382902501602

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
Lot or batch
true
Expiration date on label
true

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