FDA.report

TANBead Nucleic Acid Extraction Kit

Primary DI
04719880122158
Brand
TANBead Nucleic Acid Extraction Kit
Company
Taiwan Advanced Nanotech INC.
Model
M635A46
Published
2026-01-07
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
true

Related Records

Product Codes

CodeName
JJHClinical Sample Concentrator

Product Code Classifications

CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04719880122158PrimaryGS10

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
658613492
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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

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04719880121441TANBead Nucleic Acid Extraction Kit615A462026-01-07
04719880121458TANBead Nucleic Acid Extraction Kit615S462026-01-07
04719880122097TANBead Nucleic Acid Extraction KitM615A462026-01-07
04719880122103TANBead Nucleic Acid Extraction KitM615S462026-01-07
04719880122165TANBead Nucleic Acid Extraction KitM635S462026-01-07
04719880122370TANBead Nucleic Acid Extraction KitW615A462026-01-07
04719880122387TANBead Nucleic Acid Extraction KitW615S662026-01-07
04719880122431TANBead Nucleic Acid Extraction KitW635A462026-01-07
04719880122660TANBead Nucleic Acid Extraction KitW6TFS662026-01-07
04719880122707TANBead Nucleic Acid Extraction KitW635S662026-01-07
04719880122882TANBead Nucleic Acid Extraction Kit6TFA462026-01-07
04719880122899TANBead Nucleic Acid Extraction Kit6TFS462026-01-07
04719880122905TANBead Nucleic Acid Extraction KitM6TFA462026-01-07
04719880122912TANBead Nucleic Acid Extraction KitM6TFS462026-01-07
04719880122929TANBead Nucleic Acid Extraction KitW6TFA462026-01-07
04719880123087TANBead Nucleic Acid Extraction KitL91E0452026-01-07
04719880123889TANBead Nucleic Acid Extraction Kit61EA46-NX2026-01-07
04719880123896TANBead Nucleic Acid Extraction Kit61ES46-NX2026-01-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
04719880122905TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122912TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122929TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880123087TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880123889TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880123896TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880123902TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880123919TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07