Home GUDID 00817978023418 Vision 2
Primary DI 00817978023418
Brand Vision 2
Company PRO-LAB, INCORPORATED
Model PLA341
Device description Shigella Poly. C-1 (S. boydii 8-11)
Published 2016-11-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817978023418 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817978023418 00817978023418 817978023418 0817978023418
GMDN Terms# Term, Definition table Term Definition Multiple Salmonella species culture isolate antigen IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria isolated by culture from a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 960418395 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Contains natural rubber latex 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 00817978020011 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020028 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020035 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020080 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020103 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020110 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020226 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020233 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020240 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020257 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020264 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020271 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020288 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020295 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020301 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020318 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020325 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020332 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020349 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020356 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020363 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020370 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020387 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020394 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020400 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020417 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020424 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020431 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020448 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17 00817978020455 Vision 2 PRO-LAB, INCORPORATED GNC 2016-11-17
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