Home GUDID 00894354002304 MyCare Psychiatry
Primary DI 00894354002304
Brand MyCare Psychiatry
Company SALADAX BIOMEDICAL, INC.
Model MCP2-CAL-US
Catalog number MCP2-CAL-US
Device description Calibrator Kit 2
Published 2020-05-15
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DLJ Calibrators, Drug Specific
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DLJ Calibrators, Drug Specific Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00894354002304 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 00894354002304 00894354002304 894354002304 0894354002304
GMDN Terms# Term, Definition table Term Definition Clozapine IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of clozapine 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 144379539 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 00812101031629 ARK™ Ketamine II Calibrator ARK DIAGNOSTICS INC DLJ 2025-12-27 00812101031636 ARK™ Ketamine II Calibrator (Negative) ARK DIAGNOSTICS INC DLJ 2025-12-27 00812101031643 ARK™ Ketamine II Calibrator (50 ng/mL Cutoff) ARK DIAGNOSTICS INC DLJ 2025-12-27 00812101031650 ARK™ Ketamine II Calibrator (100 ng/mL Cutoff) ARK DIAGNOSTICS INC DLJ 2025-12-27 00850624008650 LZI Fentanyl Qualitative Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2025-10-13 00840937114568 Immunalysis IMMUNALYSIS CORP DLJ 2024-04-08 00840937114605 Immunalysis IMMUNALYSIS CORP DLJ 2024-04-08 07613336224830 MTX Calibrator Roche Diagnostics GmbH DLJ 2024-03-25 00840937103265 Immunalysis IMMUNALYSIS CORP DLJ 2023-10-26 00840937103272 Immunalysis IMMUNALYSIS CORP DLJ 2023-10-26 00840937103289 Immunalysis IMMUNALYSIS CORP DLJ 2023-10-26 00840937103296 Immunalysis IMMUNALYSIS CORP DLJ 2023-10-26 00894354002366 Beckman Coulter SALADAX BIOMEDICAL, INC. DLJ 2022-06-15 B07604120 LZI Tramadol Low Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-05-01 B07604130 LZI Tramadol Cutoff Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-05-01 B07604140 LZI Tramadol Intermediate Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-05-01 B07604150 LZI Tramadol High Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-05-01 B07605220 LZI Cotinine II Low Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-04-22 B07605230 LZI Cotinine II Cutoff Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-04-22 B07605240 LZI Cotinine II Intermediate Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-04-22 B07605250 LZI Cotinine II High Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2022-04-22 00894354002212 MyCare Psychiatry SALADAX BIOMEDICAL, INC. DLJ 2022-01-27 00850624008278 Fentanyl Qualitative Calibrator Set LIN-ZHI INTERNATIONAL, INC. DLJ 2021-10-18 00812101030509 ARK™ HS Benzodiazepine II Calibrator ARK DIAGNOSTICS INC DLJ 2021-08-31 00812101030516 ARK™ HS Benzodiazepine II Negative Calibrator ARK DIAGNOSTICS INC DLJ 2021-08-31 00812101030523 ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator ARK DIAGNOSTICS INC DLJ 2021-08-31 00812101030530 ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator ARK DIAGNOSTICS INC DLJ 2021-08-31 B07606250 LZI Oxycodone 300 High Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2021-08-19 B07606120 LZI Oxycodone 100 Low Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2021-08-18 B07606130 LZI Oxycodone 100 Cutoff Calibrator LIN-ZHI INTERNATIONAL, INC. DLJ 2021-08-18
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