Home GUDID 00819398028011 StaphTEX™
Primary DI 00819398028011
Brand StaphTEX™
Company HARDY DIAGNOSTICS
Model ST1000
Catalog number ST1000
Device description StaphTEX™ Blue test kit, 1000 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
Rx false
OTC false
Sterile false
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 00819398028042 Primary GS1 0 00819398028059 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 00819398028042 00819398028042 819398028042 0819398028042 00819398028059 00819398028059 819398028059 0819398028059 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 1000 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00819398028035 StaphTEX™ HARDY DIAGNOSTICS GTN 2022-11-23 00819398028042 StaphTEX™ HARDY DIAGNOSTICS GTN 2022-11-23 00819398028059 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