Home GUDID 00819398028035 StaphTEX™
Primary DI 00819398028035
Brand StaphTEX™
Company HARDY DIAGNOSTICS
Model ST50
Catalog number ST50
Device description StaphTEX™ Blue test kit, 50 tests.A rapid, latex agglutination slide-card test for the detection of coagulase clumping factor and/or protein A characteristics associated with Staphylococcus aureus.
Published 2022-11-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTN Antisera, Fluorescent, All Types, Staphylococcus Spp. Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00819398028035 Primary GS1 0 00819398028011 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00819398028035 00819398028035 819398028035 0819398028035 00819398028011 00819398028011 819398028011 0819398028011
GMDN Terms# Term, Definition table Term Definition Staphylococcus aureus culture isolate antigen IVD, kit, agglutination A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 039981550 Device count 50 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05032384029587 SET-RPLA, Staphylococcal Enterotoxin Kit, 20 tests OXOID LIMITED GTN 2024-06-11 05032384029594 TST-RPLA, Staphylococcal Toxic-Shock Syndrome Toxin Kit, 20 tests OXOID LIMITED GTN 2024-06-11 10628429000394 Prolex Staph Kit (100 tests) PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000400 Prolex Staph Kit (300 Tests) PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000431 Prolex Latex Reagent Control Negative (Staph) PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000455 Prolex Staph Positive Control PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000462 Prolex Staph Xtra Latex Kit (100 tests) PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000479 Prolex Staph Xtra Latex Kit (300 tests) PRO-LAB, INCORPORATED GTN 2022-12-25 10628429000509 Prolex Latex Reagent Control Negative (StaphXtra) PRO-LAB, INCORPORATED GTN 2022-12-25 00819398028042 StaphTEX™ HARDY DIAGNOSTICS GTN 2022-11-23 00819398028059 StaphTEX™ HARDY DIAGNOSTICS GTN 2022-11-23 00819398028011 StaphTEX™ HARDY DIAGNOSTICS GTN 2022-11-23 05056080501499 Staphaurex (120 test) REMEL EUROPE LIMITED GTN 2021-07-21 05056080501505 Staphaurex (400 test) REMEL EUROPE LIMITED GTN 2021-07-21 00382902409151 BD BBL™ Staphyloslide™ Latex Test Kit BECTON, DICKINSON AND COMPANY GTN 2018-05-25 00382902409168 BD BBL™ Staphyloslide™ Latex Test Kit BECTON, DICKINSON AND COMPANY GTN 2018-05-25