Home GUDID 00884999046771 RealTime
Primary DI 00884999046771
Brand RealTime
Company ABBOTT MOLECULAR INC.
Model 09N27-090
Catalog number 09N27-090
Device description Abbott RealTime ZIKA Amplification Reagent Kit
Published 2023-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name POA Reagents, Zika Virus nucleic acid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class POA Reagents, Zika Virus Nucleic Acid Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999046771 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 00884999046771 00884999046771 884999046771 0884999046771
GMDN Terms# Term, Definition table Term Definition Zika virus nucleic acid IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from Zika 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 Premarket exempt 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 00884999046757 RealTime ABBOTT MOLECULAR INC. POA 2023-09-30 00884999047068 RealTime ABBOTT MOLECULAR INC. POA 2023-09-30