FDA.reportPublic FDA data

96A Automated Viral DNA/RNA Isolation Kit

Primary DI
06973685471394
Brand
96A Automated Viral DNA/RNA Isolation Kit
Company
3D Biomedicine Science & Technology Co., Limited
Model
500 Tests
Catalog number
3000000000493
Device description
96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (Nasopharyngeal Swabs, Oropharyngeal Swabs, Saliva and Cervical Swabs) by using automatic magnetic beads technology. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
Published
2022-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
06973685471394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973685471394069736854713946973685471394

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
561011079
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0697368547136332B Automated Viral RNA Isolation Kit 64 Tests30000000001472022-05-06
0697368547137096B Automated Viral RNA Isolation Kit96 Tests 30000000001452022-05-06
06973685471035ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit64Tests31030100402021-11-30
0697368547102896A Automated Viral RNA Isolation Kit96 Tests30000000000122021-09-27
0697368547101196A Viral RNA Auto Extraction & Purification Kit96 Tests/Kit31030100592021-01-13
06973685471387ReadiMag™ gDNA Isolation Kit64 Tests30000000004492024-01-15
06973685471325ReadiMag FFPE DNA/RNA Kit64Test/Kit30000000004352023-09-25
06973685478010Automated Nucleic Acids Extraction System ANDiS 360ANDiS 36030000000000442022-05-20
06973685471332ReadiMag™ FFPE DNA Isolation Kit64 Tests30000000003842023-08-28
06973685471189ReadiMag FFPE DNA Kit64 Tests30000000003842022-05-26
06973685478003Automated Nucleic Acids Extraction System ANDiS 350ANDiS 35030000000001152021-01-12
06973685478027Automated Nucleic Acids Extraction System ANDiS 396ANDiS 39630000000004142022-09-20
06973685471912ReadiMag Pathogen Nucleic Acid Isolation Kit32 Tests30000000003592022-07-22
0697368547135696A Automated Viral DNA/RNA Isolation Kit96 Tests30000000000122022-06-13
0697368547134932A Automated Viral DNA/RNA Isolation Kit 64 Tests30000000001462022-05-06
06973685471004ANDiS Viral RNA Auto Extraction & Purification Kit64 Tests/Kit31030100462021-01-12

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
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