FDA.reportPublic FDA data

Staphaurex (400 test)

Primary DI
05056080501505
Brand
Staphaurex (400 test)
Company
REMEL EUROPE LIMITED
Model
R30859902
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
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTNAntisera, Fluorescent, All Types, Staphylococcus Spp.Microbiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851949000STAPHAUREX ZL30Wellcome Diagnostics1985-05-22GTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501505050560805015055056080501505

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus culture isolate 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 Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.

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
05032384029587SET-RPLA, Staphylococcal Enterotoxin Kit, 20 testsOXOID LIMITEDGTN2024-06-11
05032384029594TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 testsOXOID LIMITEDGTN2024-06-11
10628429000394Prolex Staph Kit (100 tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000400Prolex Staph Kit (300 Tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000431Prolex Latex Reagent Control Negative (Staph)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000455Prolex Staph Positive ControlPRO-LAB, INCORPORATEDGTN2022-12-25
10628429000462Prolex Staph Xtra Latex Kit (100 tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000479Prolex Staph Xtra Latex Kit (300 tests)PRO-LAB, INCORPORATEDGTN2022-12-25
10628429000509Prolex Latex Reagent Control Negative (StaphXtra)PRO-LAB, INCORPORATEDGTN2022-12-25
00819398028035StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028042StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028059StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
00819398028011StaphTEX™HARDY DIAGNOSTICSGTN2022-11-23
05056080501499Staphaurex (120 test)REMEL EUROPE LIMITEDGTN2021-07-21
00382902409151BD BBL™ Staphyloslide™ Latex Test KitBECTON, DICKINSON AND COMPANYGTN2018-05-25
00382902409168BD BBL™ Staphyloslide™ Latex Test KitBECTON, DICKINSON AND COMPANYGTN2018-05-25