Home GUDID 00813545025335 DNA(C.lucilae) 500 Test(L)
Primary DI 00813545025335
Brand DNA(C.lucilae) 500 Test(L)
Company SCIMEDX CORPORATION
Model D500L
Catalog number D500L
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name KTL Anti-Dna Indirect Immunofluorescent Solid Phase
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KTL Anti-Dna Indirect Immunofluorescent Solid Phase Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813545025335 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 00813545025335 00813545025335 813545025335 0813545025335
GMDN Terms# Term, Definition table Term Definition Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.
Regulatory Flags# DUNS number 155424708 Device count 1 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 08059304340222 dIFine DNA Classifier VISIA LAB SRL KTL 2024-11-08 04049016137894 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2024-09-11 04049016152989 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2023-07-05 08426951056538 NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit INOVA DIAGNOSTICS, INC. KTL 2021-03-31 04049016107057 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2020-08-28 04049016107026 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 04049016107033 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 04049016107064 IFA: Crithidia luciliae (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 04049016107149 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 04049016107156 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 04049016107187 IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern EUROIMMUN Medizinische Labordiagnostika AG KTL 2018-04-26 00813545023096 DNA(C. luciliae) 50 Test(L) SCIMEDX CORPORATION KTL 2016-09-19 00813545023119 DNA(C. luciliae) 100 Test(L) SCIMEDX CORPORATION KTL 2016-09-19 00813545020682 DNA 5 Well Slide Pack SCIMEDX CORPORATION KTL 2016-09-16 00813545020705 DNA 10 Well Slide SCIMEDX CORPORATION KTL 2016-09-16 00847817016240 Kallestad BIO-RAD LABORATORIES, INC. KTL 2016-09-12 07340058410035 DIASTAT anti-dsDNA Svar Life Science AB KTL 2016-08-12
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