Home GUDID 08426950497028 HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
Primary DI 08426950497028
Brand HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
Company INSTRUMENTATION LABORATORY COMPANY
Model 0009802116
Catalog number 0009802116
Device description HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name JJX Single (specified) analyte controls (assayed and unassayed)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950497028 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950497028 08426950497028 8426950497028
GMDN Terms# Term, Definition table Term Definition Anticardiolipin-B2-glycoprotein I complex antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Unopened controls are stable until the expiration date shown on the tube label when stored at 2-8°C Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 557223252 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08426950071068 HemosIL Normal Control ASSAYED 00020003110 00020003110 2016-09-23 08426950088646 GEM Check Coag Control-Abnormal for ACT-LR 06260060200 06260060200 2016-09-23 08426950088653 GEM Check Coag Control-Abnormal for ACT 06260060300 06260060300 2016-09-23 08426950452683 GEM Check Coag Control-Normal for Citrate PT 06260061100 06260061100 2016-09-23 08426950452713 GEM Check Coag Control-Abnormal for Citrate PT 06260061400 06260061400 2016-09-23 08426950452744 GEM Check Coag Control-Normal for ACT 06260060500 06260060500 2016-09-23 08426950452751 GEM Check Coag Control-Normal for ACT-LR 06260060600 06260060600 2016-09-23 08426950573401 HemosIL Routine Control Level 3 00020005800 00020005800 2016-09-23 08426950660668 HemosIL Abnormal Control 2 00020014000 00020014000 2016-09-23 08426950078982 HemosIL Low Abnormal Control ASSAYED 00020003210 00020003210 2016-09-23 08426950078999 HemosIL High Abnormal Control ASSAYED 00020003310 00020003310 2016-09-23 08426950087595 HemosIL Calibration Plasma 00020003700 00020003700 2016-09-23 08426950088639 GEM Check Coag Control-Abnormal for APTT 06260060100 06260060100 2016-09-23 08426950088912 Coatest APCR Control Plasma Level 1 82 2650 63 82 2650 63 2016-09-23 08426950088929 Coatest APCR Control Plasma Level 2 82 2668 63 82 2668 63 2016-09-23 08426950442189 HemosIL Special Test Control Level 2 00020012000 00020012000 2016-09-23 08426950452690 GEM Check Coag Control-Normal for APTT 06260061600 06260061600 2016-09-23 08426950452706 GEM Check Coag Control-Abnormal for PT 06260061700 06260061700 2016-09-23 08426950452737 GEM Check Coag Control-Normal for PT 06260060400 06260060400 2016-09-23 08426950453062 HemosIL Special Test Control Level 1 00020011000 00020011000 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613336234457 PreciControl Syphilis Roche Diagnostics GmbH JJX 2026-05-15 30732671309403 Pip AMITY HOLDINGS, LLC JJX 2026-04-16 10612479280509 McKesson MCKESSON MEDICAL-SURGICAL INC. JJX 2025-12-01 10840330706541 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-11-25 00021292015398 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 00021292015404 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 00021292015411 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 08058056685407 Cystatin C Controls SENTINEL CH. SPA JJX 2025-09-16 10758750035380 VITROS ORTHO CLINICAL DIAGNOSTICS JJX 2025-05-20 10758750035076 VITROS ORTHO CLINICAL DIAGNOSTICS JJX 2024-09-18 00021292015091 TRUENESS TRIVIDIA HEALTH, INC. JJX 2024-04-03 00021292015107 TRUENESS TRIVIDIA HEALTH, INC. JJX 2024-04-03 07613336166338 PreciControl beta-Amyloid (1-42) II Roche Diagnostics GmbH JJX 2022-12-13 07613336180860 CalCheck beta-Amyloid (1-42) II Roche Diagnostics GmbH JJX 2022-12-13 10673486000719 TECO DIAGNOSTICS TECO DIAGNOSTICS JJX 2022-08-09 00021292008420 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008437 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008444 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008369 TRUEcontrol TRIVIDIA HEALTH, INC. JJX 2021-01-29 00021292008383 TRUEcontrol TRIVIDIA HEALTH, INC. JJX 2021-01-29 14987481164441 uTASWako AFP-L3 Control L FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164458 uTASWako AFP-L3 Control H FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164489 uTASWako DCP Control L FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164496 uTASWako DCP Control H FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 00021292008390 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2020-10-21 00021292008406 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2020-10-21 00021292008413 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2020-10-21 00353885011969 OneTouch Verio Control Solution LifeScan Europe GmbH JJX 2020-10-14 08718734960584 Eurotrol GlucoTrol-NG Eurotrol B.V. JJX 2020-10-08 08718734960607 Eurotrol GlucoTrol-NG Eurotrol B.V. JJX 2020-10-08
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