FDA.reportPublic FDA data

Easy Amp Real-time Fluorescence Isothermal Detection System

Primary DI
06974849369083
Brand
Easy Amp Real-time Fluorescence Isothermal Detection System
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
HWTS-1600P
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974849369083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369083069748493690836974849369083

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 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
560300737
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974849369403EudemonTM AIO800HWTS-AIO800HWTS-EQ0552024-11-14
06974849369076Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600S2022-12-06
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF10002024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerHWTS-IF20002024-09-19
06974849369304Macro & Micro-Test HCG Pregnancy Test Midstream1 test/kit2023-11-27
06974849369311Macro & Micro-Test HCG Pregnancy Test Midstream20 tests/kit2023-11-27
06974849369328Macro & Micro-Test HCG Pregnancy Test Midstream3 tests/kit2023-11-27
06974849369335Macro & Micro-Test HCG Pregnancy Test Midstream5 tests/kit2023-11-27
06974849369342Macro & Micro-Test LH Test1 test/kit2023-11-27
06974849369359Macro & Micro-Test LH Test3 tests/kit2023-11-27
06974849369366Macro & Micro-Test LH Test5 tests/kit2023-11-27
06974849369373Macro & Micro-Test LH Test20 tests/kit2023-11-27
06974849369007Macro & Micro-Test Viral DNA/RNA Kit50 tests/kit2022-12-06
06974849369014Macro & Micro-Test Viral DNA/RNA Kit32 tests/kit2022-12-06
06974849369021Macro & Micro-Test Viral DNA/RNA Kit48 tests/kit2022-12-06
06974849369038Macro & Micro-Test Viral DNA/RNA Kit96 tests/kit2022-12-06
06974849369045Macro & Micro-Test Sample Release Reagent50 tests/kit2022-12-06
06974849369052Macro & Micro-Test Automatic Nucleic Acid ExtractorHWTS-NPure322022-12-06
06974849369069Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit50 tubes/kit 2mL2022-12-06
06974849369090Macro & Micro-Test Sample Collecting, Mailing & Shipping Kit50 tubes/kit 3mL2022-12-06

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