Wellcogen S pneumoniae

Primary DI
05056080501581
Brand
Wellcogen S pneumoniae
Company
REMEL EUROPE LIMITED
Model
R30859001
Published
2021-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWCAntisera, All Types, Streptococcus Pneumoniae

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWCAntisera, All Types, Streptococcus PneumoniaeMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841376000WELLCOGEN S. PNEUMONIAEWellcome Diagnostics1984-05-02GWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501581050560805015815056080501581

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713106105573ImmuView S. pneumoniae and L. pneumophila urinary antigen testSsi Diagnostica A/SGWC2022-10-25
05713106549919ImmuLex Strep-B kit, 10 x 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106663981ImmuLex S. pneumoniae Type 4, 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106732656ImmuLex Streptococcus Group Kit, 6 x 1.5 mLSsi Diagnostica A/SGWC2021-08-01
05713106732663Pneumococcus Factor 6d serum, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768549Pneumococcus Type 1 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768563Pneumococcus Type 2 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768587Pneumococcus Type 3 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768594Pneumococcus Type 4 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768648Pneumococcus Type 5 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768662Pneumococcus Type 8 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768679Pneumococcus Type 14 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768693Pneumococcus Type 20 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768716Pneumococcus Group 6 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768730Pneumococcus Group 7 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768778Pneumococcus Group 10 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106768822Pneumococcus Group 11 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769119Pneumococcus Group 12 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769133Pneumococcus Group 15 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769140Pneumococcus Group 17 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769157Pneumococcus Group 18 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769164Pneumococcus Group 33 serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769171Pneumococcus Factor 6b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769188Pneumococcus Factor 7b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769201Pneumococcus Factor 9d serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769218Pneumococcus Factor 9e serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769232Pneumococcus Factor 19b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769249Pneumococcus Factor 19c serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769256Pneumococcus Factor 22b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01
05713106769270Pneumococcus Factor 23b serum high titer, 1 mLSsi Diagnostica A/SGWC2021-08-01