Home GUDID 70887868540669 Synovasure® Alpha Defensin
Primary DI 70887868540669
Brand Synovasure® Alpha Defensin
Company CD DIAGNOSTICS, INC.
Model 00-8888-125-05
Catalog number 00-8888-125-05
Published 2022-04-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QGN Lateral flow immunochromatography assay for host infection biomarkers
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QGN Lateral Flow Immunochromatography Assay For Host Infection Biomarkers Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00887868540660 Primary GS1 0 70887868540669 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 00887868540660 00887868540660 887868540660 0887868540660 70887868540669 70887868540669
GMDN Terms# Term, Definition table Term Definition Alpha defensin 1-3 IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of alpha defensin 1-3 in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses to detect indirect markers of infection and/or inflammation.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 027871090 Device count 5 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00887868540660 Synovasure® Alpha Defensin 00-8888-125-05 00-8888-125-05 2022-04-07 00887868540653 Synovasure® Alpha Defensin 00-8888-125-01 00-8888-125-01 2022-02-04 00887868540677 Synovasure® Alpha Defensin 00-8888-125-10 00-8888-125-10 2022-02-04 00887868540684 Synovasure® Alpha Defensin 00-8888-125-30 00-8888-125-30 2022-02-04 00887868540691 Synovasure® Alpha Defensin 00-8888-125-02 00-8888-125-02 2021-11-21 00887868358814 Synovasure® Alpha Defensin 00-8888-125-01 00-8888-125-01 2019-07-09 00887868358821 Synovasure® Alpha Defensin 00-8888-125-05 00-8888-125-05 2019-07-09 00887868358838 Synovasure® 00-8888-125-10 00-8888-125-10 2019-07-09 00887868358845 Synovasure® 00-8888-125-30 00-8888-125-30 2019-07-09 00887868358852 Synovasure® Alpha Defensin 00-8888-125-02 00-8888-125-02 2019-07-09
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00887868540660 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2022-04-07 00887868540653 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2022-02-04 00887868540677 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2022-02-04 00887868540684 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2022-02-04 00887868540691 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2021-11-21 00887868358814 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2019-07-09 00887868358821 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2019-07-09 00887868358838 Synovasure® CD DIAGNOSTICS, INC. QGN 2019-07-09 00887868358845 Synovasure® CD DIAGNOSTICS, INC. QGN 2019-07-09 00887868358852 Synovasure® Alpha Defensin CD DIAGNOSTICS, INC. QGN 2019-07-09