FDA.reportPublic FDA data

Macro & Micro-Test Automatic Nucleic Acid Extractor

Primary DI
06974849369052
Brand
Macro & Micro-Test Automatic Nucleic Acid Extractor
Company
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Model
HWTS-NPure32
Published
2022-12-06
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
false

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974849369052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974849369052069748493690526974849369052

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic separation instrument IVD, molecularAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques. It is a software-controlled, liquid handling robotic instrument that processes solutions using sequential immersion of magnetized rods, to attract labelled molecules, and rotation of demagnetized rods to create a new suspension/solution, and is typically used for nucleic acid isolation procedures.

Regulatory Flags#

DUNS number
560300737
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
06974849369403EudemonTM AIO800HWTS-AIO800HWTS-EQ0552024-11-14
06974849369076Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600S2022-12-06
06974849369083Easy Amp Real-time Fluorescence Isothermal Detection SystemHWTS-1600P2022-12-06
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122899TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07