Phadebact CSF Test

Primary DI
07350049850221
Brand
Phadebact CSF Test
Company
Mkl Diagnostics AB
Model
10-5592-12
Catalog number
10-5592-12
Published
2016-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
07350049850221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350049850221073500498502217350049850221

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
350472667
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350049850122Phadebact Pneumococcus Test10-5576-122018-08-20
07350049850160Phadebact Streptococcus Test10-5583-122018-08-20
07350049850177Phadebact Strep A Test10-5584-122018-08-20
07350049850184Phadebact Strep B Test10-5585-122018-08-20
07350049850191Phadebact Strep D Test10-5586-122018-08-20
07350049850207Phadebact Strep F Test10-5587-122018-08-20
07350049850214Phadebact Strep Positive Controls10-5590-122018-08-20
07350049850238Phadebact CSF Positive Controls10-5593-122018-08-20
07350049850245Phadebact GC Positive Controls10-5594-122018-08-20
07350049850115Phadebact Haemophilus Test10-5575-1210-5575-122016-11-17
07350049850269Phadebact Monoclonal GC Test 10-6419-1210-6419-122016-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056080501567EDTA SolutionREMEL EUROPE LIMITEDGTJ2021-07-21
05056080500973NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500980NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080500997NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501130NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501147NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501154NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501161NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501178NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501185NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501192NAREMEL EUROPE LIMITEDGTJ2016-09-24
05056080501208NAREMEL EUROPE LIMITEDGTJ2016-09-24
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
30382902523506BD Directigen™ Meningitis Test Negative Control ReagentBECTON, DICKINSON AND COMPANYGTJ2016-05-19
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