Home GUDID 00840937108925 Immunalysis Corporation
Primary DI 00840937108925
Brand Immunalysis Corporation
Company IMMUNALYSIS CORPORATION
Model 10001-25
Device description Immunalysis Corporation Multi-Drug Calibrator Level 2 (25 mL)
Published 2016-12-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name DKB Calibrators, drug mixture
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DKB Calibrators, Drug Mixture Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840937108925 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 00840937108925 00840937108925 840937108925 0840937108925
GMDN Terms# Term, Definition table Term Definition Multiple-therapy therapeutic drug monitoring IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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 080589004 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 00840937114636 Immunalysis IMMUNALYSIS CORP DKB 2024-04-19 00840937114643 Immunalysis IMMUNALYSIS CORP DKB 2024-04-19 00840937114650 Immunalysis IMMUNALYSIS CORP DKB 2024-04-19 00840937114667 Immunalysis IMMUNALYSIS CORP DKB 2024-04-19 20613647025295 Fisherbrand FISHER SCIENTIFIC COMPANY L.L.C. DKB 2023-06-20 00840937112083 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2021-02-05 00840937112090 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2021-02-05 00840937112106 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2021-02-05 00840937112113 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2021-02-05 00811727016850 Pointe Universal Negative Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017550 Pointe Multi-Analyte Set C Urine DAU Low Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017567 Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017574 Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017581 Pointe Multi-Analyte Set C Urine DAU High Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017611 Pointe Multi-Analyte Set D Urine DAU Negative Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017628 Pointe Multi-Analyte Set D Urine DAU Low Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017635 Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017642 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017659 Pointe Multi-Analyte Set D Urine DAU High Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017680 Pointe Multi-Analyte E DAU Negative Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017697 Pointe Multi-Analyte E DAU Low Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017703 Pointe Multi-Analyte E DAU Cutoff Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017710 Pointe Multi-Analyte E DAU Intermediate Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00811727017727 Pointe Multi-Analyte E DAU High Calibrator POINTE SCIENTIFIC, INC. DKB 2020-09-25 00380740179342 Alinity ABBOTT LABORATORIES DKB 2020-05-11 00380740179359 Alinity ABBOTT LABORATORIES DKB 2020-05-11 00380740179366 Alinity ABBOTT LABORATORIES DKB 2020-05-11 00840937111895 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2020-03-31 00840937111918 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2020-03-31 00840937111925 Immunalysis Corporation IMMUNALYSIS CORPORATION DKB 2020-03-31