Home GUDID 00845714001017 IMMCO DIAGNOSTICS
Primary DI 00845714001017
Brand IMMCO DIAGNOSTICS
Company IMMCO DIAGNOSTICS, INC.
Model 1107-1
Catalog number 1107-1
Device description Autoantibody Test System 1 - Mouse Kidney Substrate
Published 2016-09-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LKJ Antinuclear Antibody, Antigen, Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKJ Antinuclear Antibody, Antigen, Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845714001017 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 00845714001017 00845714001017 845714001017 0845714001017
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 079935300 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B3507207900 Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit Gold Standard Diagnostics Corporation LKJ 2025-02-26 07333066014876 EliA Ro60 Well Phadia AB LKJ 2022-09-14 07333066014906 EliA Ro52 Well Phadia AB LKJ 2022-09-14 05391516747493 Immco CLARK LABORATORIES, INC. LKJ 2019-12-30 05391516746595 Immco Diagnostics CLARK LABORATORIES, INC. LKJ 2019-10-25 00845714003233 Immco Diagnostics IMMCO DIAGNOSTICS, INC. LKJ 2018-06-05 00845714003219 Immco Diagnostics, Inc. IMMCO DIAGNOSTICS, INC. LKJ 2017-02-02 00840733101014 ANA Screen ELISA Test Kit MERIDIAN BIOSCIENCE, INC. LKJ 2016-09-23 07333066010564 EliA U1RNP Well Phadia AB LKJ 2016-09-23 07333066010571 EliA Sm Well Phadia AB LKJ 2016-09-23 07333066010588 EliA Ro Well Phadia AB LKJ 2016-09-23 07333066010595 EliA La Well Phadia AB LKJ 2016-09-23 07333066010601 EliA CENP Well Phadia AB LKJ 2016-09-23 00845714001949 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001956 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001963 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714001970 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714003011 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714003223 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714003226 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714003448 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714003530 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714004322 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714004339 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-23 00845714000003 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21 00845714000010 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21 00845714000249 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21 00845714000829 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21 00845714000836 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21 00845714000843 IMMCO DIAGNOSTICS IMMCO DIAGNOSTICS, INC. LKJ 2016-09-21
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