Home GUDID 10628429000400 Prolex Staph Kit (300 Tests)
Primary DI 10628429000400
Brand Prolex Staph Kit (300 Tests)
Company PRO-LAB, INCORPORATED
Model PL.081B
Catalog number PL.081B
Device description The Prolex™ Staph Latex Kit provides a rapid platform for the identificationof Staphylococcal isolates particularly Staphylococcus aureus which possessbound coagulase (clumping factor) and / or protein A from other species ofstaphylococc
Published 2022-12-25
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 10628429000400 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10628429000400 10628429000400
GMDN Terms# Term, Definition table Term Definition Multiple Staphylococcus species nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, and/or genes conferring antimicrobial resistance, toxin production or virulence, from multiple species of Staphylococcus bacteria (e.g., S. aureus, S. epidermidis, S. hominis, S. warneri, S. simulans, S. lugdunensis) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).
Regulatory Flags# DUNS number 960418395 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 DI Brand Model Catalog Published 10628429001223 AmnioTest (Nitrazine yellow swab) PL.901 PL.901 2022-12-26 20628429001220 AmnioTest (Nitrazine yellow swab 20 box) PL.901-20 PL.901-20 2022-12-26 30628429001227 AmnioTest (Nitrazine yellow swab 100 box) PL.901 PL.901 2022-12-26 10628429001742 Legionella DFA Mounting Medium PL.213 PL.213 2022-12-25 10628429001049 Prolex E. coli O157 Latex Test Reagent Kit (50 tests) PL.070B PL.070B 2022-12-26 10628429001056 Prolex E. coli O157 Latex Test Reagent Kit (100 tests) PL.071B PL.071B 2022-12-26 10628429001100 Prolex E. coli O157 Latex Reagent Control Negative PL.076B PL.076B 2022-12-26 10628429001124 Prolex E. coli Non-O157 Identification Kit PL.1070 PL.1070 2022-12-26 10628429001131 Prolex E. coli O26 Latex Reagent PL.1071 PL.1071 2022-12-26 10628429001148 Prolex E. coli O45 Latex Reagent PL.1072 PL.1072 2022-12-26 10628429001155 Prolex E. coli O103 Latex Reagent PL.1073 PL.1073 2022-12-26 10628429001162 Prolex E. coli O111 Latex Reagent PL.1074 PL.1074 2022-12-26 10628429001179 Prolex E. coli O121 Latex Reagent PL.1075 PL.1075 2022-12-26 10628429001186 Prolex E. coli O145 Latex Reagent PL.1076 PL.1076 2022-12-26 10628429001193 Prolex E. coli Non-O157 Negative Control Latex Reagent PL.1077 PL.1077 2022-12-26 10628429001209 Prolex E. coli O91 Latex Reagent PL.1078 PL.1078 2022-12-26 10628429001216 E. coli O157 Antiserum (3ml) PL.6250 PL.6250 2022-12-26 10628429001254 AmnioTest Colour Cards PL.902 PL.902 2022-12-26 10628429000080 Prolex Streptococcal Grouping Latex Kit PL.030 PL.030 2022-12-25 10628429000110 Prolex Streptococcal Grouping Reagent Latex Suspension Group A PL.031 PL.031 2022-12-25
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 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 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