Home GUDID 00840937110676 Immunalysis
Primary DI 00840937110676
Brand Immunalysis
Company IMMUNALYSIS CORP
Model C341UR-5-2-1000
Catalog number C341UR-5-2-1000
Device description Ethyl Glucuronide Control Set
Published 2017-10-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name LAS Drug specific control materials
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LAS Drug Specific Control Materials Clinical Toxicology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840937110676 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 00840937110676 00840937110676 840937110676 0840937110676
GMDN Terms# Term, Definition table Term Definition Ethyl glucuronide (EtG) 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 ethyl glucuronide (EtG), a metabolite of ethanol alcohol (ETOH), in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 002804244 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# 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 B800ACETAHIGHV2UADX0 ACETAMINOPHEN PLUS HIGH V2 UTAK LABORATORIES, INC. LAS 2026-01-16 B800ACETALOWV2UADX0 ACETAMINOPHEN PLUS LOW V2 UTAK LABORATORIES, INC. LAS 2026-01-16 B80044600WBF10TCH0 BLANK WHOLE BLOOD 10ML UTAK LABORATORIES, INC. LAS 2025-10-29 B800AED1V3SHCMC0 AED LEVEL 1 V3 UTAK LABORATORIES, INC. LAS 2025-08-25 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 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 B800AEDSSCH0 AED PLUS UTAK LABORATORIES, INC. LAS 2024-07-17 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 B800ACETAUV4PM0 ACETAMINOPHEN PLUS V4 UTAK LABORATORIES, INC. LAS 2024-03-12 B80092021IDC0 SSRI 12 LEVEL 2 UTAK LABORATORIES, INC. LAS 2024-03-06 B800ACE250SFBSRHS0 ACETONE 250 MG/DL UTAK LABORATORIES, INC. LAS 2024-02-27 B80088121CDFLLTRWVDTL0 CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC. LAS 2024-02-20 B800ACIDNEUTQC0 ACID-NEUT QC UTAK LABORATORIES, INC. LAS 2024-02-16