Home GUDID 00195226000030 HemosIL Apixaban Controls
Primary DI 00195226000030
Brand HemosIL Apixaban Controls
Company INSTRUMENTATION LABORATORY COMPANY
Model 0020015300
Catalog number 00020015300
Device description HemosIL Apixaban Controls kit consists of:1. Apixaban Low Control (Cat. No. 0020015310): 5 x 1 mL vials 2. Apixaban High Control (Cat. No. 0020015320): 5 x 1 mL vials
Published 2021-04-16
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 GGN Plasma, Coagulation Control LAS Drug Specific Control Materials
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGN Plasma, Coagulation Control Hematology 2 LAS Drug Specific Control Materials Clinical Toxicology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00195226000030 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 00195226000030 00195226000030 195226000030 0195226000030
GMDN Terms# Term, Definition table Term Definition Coagulation factor Xa inhibitor 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 activated coagulation factor Xa inhibitor in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 557223252 Device count 1 Premarket exempt true 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 B8007HMG75UFKP0 7-HMG 75 NG/ML UTAK LABORATORIES, INC. LAS 2026-04-02 08426951011131 HemosIL CL Multi-Ab Controls INSTRUMENTATION LABORATORY COMPANY GGN 2025-10-30 B80044600WBF10TCH0 BLANK WHOLE BLOOD 10ML UTAK LABORATORIES, INC. LAS 2025-10-29 B8006TGRQC1UK0 6TGR PLUS QC LEVEL 1 UTAK LABORATORIES, INC. LAS 2025-08-06 B8006TGRQC2UK0 6TGR PLUS QC LEVEL 2 UTAK LABORATORIES, INC. LAS 2025-08-06 B8006TGRQC3UK0 6TGR PLUS QC LEVEL 3 UTAK LABORATORIES, INC. LAS 2025-08-06 08718734962724 CueSee® Coag Eurotrol B.V. GGN 2025-04-08 08718734962731 CueSee® Coag Eurotrol B.V. GGN 2025-04-08 08718734962748 CueSee® Coag Eurotrol B.V. GGN 2025-04-08 08718734962755 CueSee® Coag Eurotrol B.V. GGN 2025-04-08 08718734962762 CueSee® Coag Eurotrol B.V. GGN 2025-04-08 B80088121CDFASC0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2025-03-24 B80091801UAL0 BUPRENORPHINE HYDROLYSIS QC UTAK LABORATORIES, INC. LAS 2025-01-13 B80088121CDFL500NPM0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-12-20 B80044600WBF100MLRH0 BLANK WHOLE BLOOD 100ML UTAK LABORATORIES, INC. LAS 2024-12-11 B80090000UFLTI0 NICOTINE PLUS LEVEL 1 UTAK LABORATORIES, INC. LAS 2024-09-30 B80090001UFLTI0 NICOTINE PLUS LEVEL 2 UTAK LABORATORIES, INC. LAS 2024-09-30 B80088121CDFF10NJSP0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-09-18 B80088121CDFL50PML0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-09-05 B80011511050SMXHFAH0 BLANK HAIR MATRIX UTAK LABORATORIES, INC. LAS 2024-08-23 B80044600WBFPOSAFT0 POSITIVE WHOLE BLOOD UTAK LABORATORIES, INC. LAS 2024-05-20 B80088121CDFF10FS0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-05-06 B8007AMINOHIGHUPM0 7-AMINOCLONAZEPAM HIGH UTAK LABORATORIES, INC. LAS 2024-05-03 B8007AMINOLOWUPM0 7-AMINOCLONAZEPAM LOW UTAK LABORATORIES, INC. LAS 2024-05-03 B80088121CDFF100PDH0 CERTIFIED DRUG FREE URINE 100ML UTAK LABORATORIES, INC. LAS 2024-04-30 B80066815V3HRLC0 HIGH RANGE TRACE ELEMENTS V3 UTAK LABORATORIES, INC. LAS 2024-04-03 B80066816V3NRLC0 NORMAL RANGE TRACE ELEMENTS V3 UTAK LABORATORIES, INC. LAS 2024-04-03 B80088121CDFLLTRWVDTL0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-02-20 B80088121CDFL100MM0 CERTIFIED DRUG FREE URINE 100 ML UTAK LABORATORIES, INC. LAS 2024-02-05 B80088121CDFL100ABS0 CERTIFIED DRUG FREE URINE 100 ML UTAK LABORATORIES, INC. LAS 2023-12-18
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