FDA.reportPublic FDA data

PathoDx Extraction Reagent 3

Primary DI
05056080501345
Brand
PathoDx Extraction Reagent 3
Company
REMEL EUROPE LIMITED
Model
R62060
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
GTZAntisera, All Groups, Streptococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTZAntisera, All Groups, Streptococcus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842383000PATHO DX LATEX AGGLUTINATION STREP ADiagnostic Products Corp.1984-07-02GTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501345050560805013455056080501345

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Streptococcus serological grouping IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture.

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
05032384013043Latex Grouping Reagent AOXOID LIMITEDGTZ2024-06-19
05032384013050Latex Grouping Reagent BOXOID LIMITEDGTZ2024-06-19
05032384013067Latex Grouping Reagent COXOID LIMITEDGTZ2024-06-19
05032384013074Latex Grouping Reagent DOXOID LIMITEDGTZ2024-06-19
05032384013081Latex Grouping Reagent FOXOID LIMITEDGTZ2024-06-19
05032384013098Latex Grouping Reagent GOXOID LIMITEDGTZ2024-06-19
05032384519552PathoDxtra Strep Grouping Kit (60 tests)OXOID LIMITEDGTZ2024-06-19
05032384519569PathoDxtra Extraction ReagentsOXOID LIMITEDGTZ2024-06-19
05032384519576PATHODXTRA STREP GROUPING REAGENT SETOXOID LIMITEDGTZ2024-06-19
05032384519606PATHODXTRA DISPOSABLE CARDSOXOID LIMITEDGTZ2024-06-19
05032384519835PATHODXTRA STREP GROUP A LATEXOXOID LIMITEDGTZ2024-06-19
05032384519842PATHODXTRA STREP GROUP B LATEXOXOID LIMITEDGTZ2024-06-19
05032384519859PATHODXTRA STREP GROUP C LATEXOXOID LIMITEDGTZ2024-06-19
05032384519866PATHODXTRA STREP GROUP D LATEXOXOID LIMITEDGTZ2024-06-19
05032384519873PATHODXTRA STREP GROUP F LATEXOXOID LIMITEDGTZ2024-06-19
05032384519880PATHODXTRA STREP GROUP G LATEXOXOID LIMITEDGTZ2024-06-19
05032384519897PathoDxtra Polyvalent Positive ControlOXOID LIMITEDGTZ2024-06-19
05032384012954Oxoid Reaction CardsOXOID LIMITEDGTZ2024-06-18
05032384013036Oxoid Streptococcal Grouping KitOXOID LIMITEDGTZ2024-06-18
10628429000080Prolex Streptococcal Grouping Latex KitPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000110Prolex Streptococcal Grouping Reagent Latex Suspension Group APRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000134Prolex Streptococcal Grouping Reagent Latex Suspension Group BPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000158Prolex Streptococcal Grouping Reagent Latex Suspension Group CPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000172Prolex Streptococcal Grouping Reagent Latex Suspension Group DPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000196Prolex Streptococcal Grouping Reagent Latex Suspension Group FPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000219Prolex Streptococcal Grouping Reagent Latex Suspension Group GPRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000233Prolex Streptococcal Grouping Reagent Extraction Reagent 1PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000240Prolex Streptococcal Grouping Reagent Extraction Reagent 2PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000257Prolex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml)PRO-LAB, INCORPORATEDGTZ2022-12-25
10628429000271Prolex Streptococcal Grouping Reagent Polyvalent Positive ControlPRO-LAB, INCORPORATEDGTZ2022-12-25