FDA.report

Shineway

Primary DI
16974900600039
Brand
Shineway
Company
Zhuhai Shineway Biotech Co.,Ltd
Model
SWM-02
Published
2022-08-22
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

Related Records

Product Codes

CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications

CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
16974900600039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1697490060003916974900600039

GMDN Terms

TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedAn electrically-powered 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 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, and operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods

Method
High-level Disinfectant

Regulatory Flags

DUNS number
703646346
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
true

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Primary DIBrandModelCatalogPublished
16974900600091ShinewaySWSI-022022-10-09

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