Home GUDID 00884999049086 RealTime
Primary DI 00884999049086
Brand RealTime
Company ABBOTT MOLECULAR INC.
Model 09N77-085
Catalog number 09N77-085
Device description Abbott RealTime SARS-CoV-2 Control Kit
Published 2020-04-27
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 QJR Reagents, 2019-novel coronavirus nucleic acid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QJR Reagents, 2019-Novel Coronavirus Nucleic Acid Unknown N
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999049086 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 00884999049086 00884999049086 884999049086 0884999049086
GMDN Terms# Term, Definition table Term Definition SARS-CoV-2 nucleic acid 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 nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, 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 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 00810096640031 Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 Biomeme, Inc. QJR 2022-12-02 00810096640048 Biomeme SARS-CoV-2 Go-Strips Kit Biomeme, Inc. QJR 2022-12-02 00810096640055 Biomeme SARS-CoV-2 Go-Strips Biomeme, Inc. QJR 2022-12-02 00810096640062 Biomeme Void Filling Caps Biomeme, Inc. QJR 2022-12-02 00810096640079 Biomeme RNA Process Control (RPC) Kiit Biomeme, Inc. QJR 2022-12-02 00810096640086 Biomeme SARS-CoV-2 Go-Plates Kit Biomeme, Inc. QJR 2022-12-02 00810096640093 Biomeme SARS-CoV-2 Go-Plates Biomeme, Inc. QJR 2022-12-02 00810096640109 Biomeme DNA/RNA Preservation Buffer (100/pk) Biomeme, Inc. QJR 2022-12-02 00810096640017 Biomeme Franklin three9 Real-Time PCR Thermocycler Biomeme, Inc. QJR 2022-12-02 00810096640024 Biomeme Franklin three9 Real-Time PCR Thermocycler Biomeme, Inc. QJR 2022-12-02 10810096640038 Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0 Biomeme, Inc. QJR 2022-12-02 10810096640045 Biomeme SARS-CoV-2 Go-Strips Kit Biomeme, Inc. QJR 2022-12-02 10810096640052 Biomeme SARS-CoV-2 Go-Strips Biomeme, Inc. QJR 2022-12-02 10810096640069 Biomeme Void Filling Caps Biomeme, Inc. QJR 2022-12-02 10810096640076 Biomeme RNA Process Control (RPC) Kiit Biomeme, Inc. QJR 2022-12-02 10810096640083 Biomeme SARS-CoV-2 Go-Plates Kit Biomeme, Inc. QJR 2022-12-02 10810096640090 Biomeme SARS-CoV-2 Go-Plates Biomeme, Inc. QJR 2022-12-02 10810096640106 Biomeme DNA/RNA Preservation Buffer (100/pk) Biomeme, Inc. QJR 2022-12-02 00810096640116 Biomeme Franklin three9 Real-Time PCR Thermocycler Biomeme, Inc. QJR 2022-12-02 00810096640123 Biomeme Franklin three9 Real-Time PCR Thermocycler Biomeme, Inc. QJR 2022-12-02 00810096640130 Biomeme GoDx App for US Biomeme, Inc. QJR 2022-12-02 00884999050457 Alinity m ABBOTT MOLECULAR INC. QJR 2022-09-08 00884999050464 Alinity m ABBOTT MOLECULAR INC. QJR 2022-09-08 00884999050242 Alinity m ABBOTT MOLECULAR INC. QJR 2022-05-20 00884999050280 Alinity m ABBOTT MOLECULAR INC. QJR 2022-05-19 00884999050211 Alinity m ABBOTT MOLECULAR INC. QJR 2021-08-20 00884999050136 Alinity m ABBOTT MOLECULAR INC. QJR 2021-07-16 00884999050020 Alinity m ABBOTT MOLECULAR INC. QJR 2021-05-17 00884999049390 Alinity m ABBOTT MOLECULAR INC. QJR 2021-03-10 00884999049406 Alinity m ABBOTT MOLECULAR INC. QJR 2021-03-10
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