Home GUDID 30884999049131 RealTime
Primary DI 30884999049131
Brand RealTime
Company ABBOTT MOLECULAR INC.
Model 09N77-055
Catalog number 09N77-055
Device description Abbott Universal Collection Kit
Published 2020-06-10
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 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 20884999049134 Package GS1 50 In Commercial Distribution 30884999049131 Package GS1 10 In Commercial Distribution 00884999049130 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 20884999049134 20884999049134 30884999049131 30884999049131 00884999049130 00884999049130 884999049130 0884999049130
GMDN Terms# Term, Definition table Term Definition General specimen transport medium collection kit IVD A collection of in vitro diagnostic devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it is not dedicated to a body region)] for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It includes a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 878263359 Device count 1 DM exempt false Premarket exempt true 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 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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