Home GUDID 00380740044831 ARCHITECT
Primary DI 00380740044831
Brand ARCHITECT
Company ABBOTT LABORATORIES
Model 6K54-21
Catalog number 06K5421
Device description Quantia ASO Control I
Published 2018-07-31
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 JJT Enzyme controls (assayed and unassayed)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740044831 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 00380740044831 00380740044831 380740044831 0380740044831
GMDN Terms# Term, Definition table Term Definition Plasma protein IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 079226220 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 false 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 00893038002944 Cholestech LDX™ Alere San Diego, Inc. JJT 2023-12-20 00380740156381 ARCHITECT ABBOTT LABORATORIES JJT 2020-03-03 00380740156398 ARCHITECT ABBOTT LABORATORIES JJT 2020-03-03 04015630947119 PreciControl ISD Roche Diagnostics GmbH JJT 2019-01-14 04015630947126 CalCheck ISD Roche Diagnostics GmbH JJT 2019-01-14 00380740045593 ARCHITECT ABBOTT LABORATORIES JJT 2018-07-31 00856743007024 Cardiac Control Marker MORE DIAGNOSTICS INC JJT 2018-03-31 00856743007031 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-31 00856743007048 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-31 00893038002524 Alere Cholestech LDX® Alere San Diego, Inc. JJT 2018-03-30 00856743007017 Cardiac Marker Control MORE DIAGNOSTICS INC JJT 2018-03-30 M52551340 CK/LD Isoenzyme Control (5 x 2 mL) HELENA LABORATORIES CORPORATION JJT 2017-03-17 00847661001225 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00847661001232 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00847661002154 Liquichek BIO-RAD LABORATORIES, INC. JJT 2017-01-09 00852553007049 Enzymer Verifier Kit VERICHEM LABORATORIES, INC. JJT 2016-11-29 00852553007056 Enzymer ER Verifier Kit VERICHEM LABORATORIES, INC. JJT 2016-11-29 00852553007131 Enzymer ER Verifier, Level G VERICHEM LABORATORIES, INC. JJT 2016-11-29 00725609000205 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000212 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000441 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00725609000458 SPOTCHECK ASTORIA-PACIFIC, INC. JJT 2016-10-14 00384840518902 Prodigy AutoCode Blood Glucose Monitoring System Prodigy Diabetes Care, LLC JJT 2016-09-22 00038481518505 Prodigy AutoCode Blood Glucose Monitoring System PRODIGY DIABETES CARE, LLC JJT 2016-09-22
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