BD Directigen™ Meningitis Combo Test Kit

Primary DI
00382902523604
Brand
BD Directigen™ Meningitis Combo Test Kit
Company
BECTON, DICKINSON AND COMPANY
Model
252360
Catalog number
252360
Device description
BD Directigen™ Meningitis Combo Test Kit
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
GTJANTISERA, ALL GROUPS, N. MENINGITIDIS

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952791000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952791000DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems Preanalytic1996-05-30GTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902523604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902523604003829025236043829025236040382902523604

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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