FDA.reportPublic FDA data

Fluorescence Quantitative PCR Detection System

Primary DI
06975318150096
Brand
Fluorescence Quantitative PCR Detection System
Company
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
Model
MQ4044-4
Published
2022-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975318150096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975318150096069753181500966975318150096

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
723289634
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975318150010Fluorescence Quantitative PCR Detection SystemMQ4164-162022-11-28
06975318150027Fluorescence Quantitative PCR Detection SystemMQ4042-42022-11-28
06975318150034Fluorescence Quantitative PCR Detection SystemMQ4044-42022-11-28
06975318150041Fluorescence Quantitative PCR Detection SystemMQ4082-82022-11-28
06975318150058Fluorescence Quantitative PCR Detection SystemMQ4084-82022-11-28
06975318150065Fluorescence Quantitative PCR Detection SystemMQ4162-162022-11-28
06975318150072Fluorescence Quantitative PCR Detection SystemMQ4164-162022-11-28
06975318150089Fluorescence Quantitative PCR Detection SystemMQ4042-42022-11-28
06975318150102Fluorescence Quantitative PCR Detection SystemMQ4082-82022-11-28
06975318150119Fluorescence Quantitative PCR Detection SystemMQ4084-82022-11-28
06975318150126Fluorescence Quantitative PCR Detection SystemMQ4162-162022-11-28

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