FDA.reportPublic FDA data

GN 7000 Akso PCR System

Primary DI
06954414795394
Brand
GN 7000 Akso PCR System
Company
Getein Biotech,Inc
Model
GP6004
Published
2026-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06954414795394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06954414795394069544147953946954414795394

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended 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 quantified 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.

Regulatory Flags#

DUNS number
542973494
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06954414726404T3 Fast Test Kit (Immunofluorescence Assay)IF1022IF10222026-07-10
06954414726411T3 Fast Test Kit (Immunofluorescence Assay)IF1022IF10222026-07-10
06954414726428T4 Fast Test Kit (Immunofluorescence Assay)IF10232026-07-10
06954414726435T4 Fast Test Kit (Immunofluorescence Assay)IF10232026-07-10
06954414728125MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414728385MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414728583MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414728811MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414731101MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414731118MAGICL T4 (CLIA)CLIA3007A2026-07-10
06954414731316MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414731323MAGICL T4 (CLIA)CLIA3007A2026-07-10
06954414731682MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414734072MAGICL Tg (CLIA)CLIA3074A2026-07-10
06954414735123T3 Fast Test Kit (Immunofluorescence Assay)IF2022IF20222026-07-10
06954414735147T4 Fast Test Kit (Immunofluorescence Assay)IF20232026-07-10
06954414735598MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414735635MAGICL FT3 (CLIA)CLIA3008ACLIA3008A2026-07-10
06954414735932MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10
06954414735956MAGICL T3 (CLIA)CLIA3006ACLIA3006A2026-07-10

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