Home GUDID B07609770 LZI Fentanyl Level 1 Control
Primary DI B07609770
Brand LZI Fentanyl Level 1 Control
Company LIN-ZHI INTERNATIONAL, INC.
Model 0977
Catalog number 0977
Device description 5 mL/bottle Concentration: 0.5 ng/mL of Fentanyl
Published 2026-07-17
Public version status New
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 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 B07609770 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Fentanyl 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 fentanyl in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 840839190 Device count 1 DM exempt false Premarket exempt true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B07609700 LZI Fentanyl III Enzyme Immunoassay 0970 0970 2026-07-17 B07609710 LZI Fentanyl III Enzyme Immunoassay 0971 0971 2026-07-17 B07609730 LZI Fentanyl Cutoff Calibrator 0973 0973 2026-07-17 B07609780 LZI Fentanyl Level 2 Control 0978 0978 2026-07-17 00850624008643 Fentanyl II Enzyme Immunoassay 10427531190 10427531190 2025-11-17 00850624008544 LZI Fentanyl III Enzyme Immunoassay C82916 C82916 2025-10-13 00850624008650 LZI Fentanyl Qualitative Calibrator D26784 D26784 2025-10-13 00850624008667 LZI Fentanyl Level 1 Control D26785 D26785 2025-10-13 00850624008674 LZI Fentanyl Level 2 Control D26786 D26786 2025-10-13 00850624008681 LZI Fentanyl III Enzyme Immunoassay D29739 D29739 2025-10-13 00850624008636 Fentanyl Control Set 10426667190 10426667190 2025-06-06 B07600400 Amphetamines Enzyme Immunoassay 0040 0040 2016-07-05 B07600410 Amphetamines Enzyme Immunoassay 0041 0041 2016-07-05 B07601000 Amphetamines 500 Enzyme Immunoassay 0100 0100 2016-07-05 B07601010 Amphetamines 500 Enzyme Immunoassay 0101 0101 2016-07-05 B07601600 Ecstasy Enzyme Immunoassay 0160 0160 2016-07-05 B07601610 Ecstasy Enzyme Immunoassay 0161 0161 2016-07-05 B07601620 Ecstasy DAU Calibrator, Low Calibrator 0162 0162 2016-07-05 B07601630 Ecstasy DAU Calibrator, Cutoff Calibrator 0163 0163 2016-07-05 B07601640 Ecstasy DAU Calibrator, Intermediate Calibrator 0164 0164 2016-07-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B07609780 LZI Fentanyl Level 2 Control LIN-ZHI INTERNATIONAL, INC. LAS 2026-07-17 B800FENTHIGHWBSCFL0 FENTANYL PLUS HIGH UTAK LABORATORIES, INC. LAS 2026-07-14 B800FENTLOWWBSCFL0 FENTANYL PLUS LOW UTAK LABORATORIES, INC. LAS 2026-07-14 B800LCDOAWBFMSP0 DRUGS OF ABUSE UTAK LABORATORIES, INC. LAS 2026-07-07 B800THCCTLMFMSP0 THC CONTROL UTAK LABORATORIES, INC. LAS 2026-07-07 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 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 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