Home GUDID 00884999050785 Alinity m
Primary DI 00884999050785
Brand Alinity m
Company ABBOTT MOLECULAR INC.
Model 09R06-085
Catalog number 09R06-085
Device description Alinity m MPXV CTRL Kit
Published 2022-10-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name QTP Reagents, monkeypox virus nucleic acid.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QTP Reagents, Monkeypox Virus Nucleic Acid. Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999050785 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 00884999050785 00884999050785 884999050785 0884999050785
GMDN Terms# Term, Definition table Term Definition Monkeypox virus nucleic acid IVD, reagent A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from monkeypox virus in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius -15 Degrees Celsius
Regulatory Flags# DUNS number 878263359 Device count 1 DM exempt true 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 00884999050778 Alinity m ABBOTT MOLECULAR INC. QTP 2023-09-30 00884999050792 Alinity m ABBOTT MOLECULAR INC. QTP 2022-10-21
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