32A Automated Viral DNA/RNA Isolation Kit 3000000000146

GUDID 06973685471349

32A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (nasopharyngeal, 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.

3D Biomedicine Science & Technology Co., Limited

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD
Primary Device ID06973685471349
NIH Device Record Key7f9200c0-7dd4-41f9-8bc4-49cce265866d
Commercial Distribution StatusIn Commercial Distribution
Brand Name32A Automated Viral DNA/RNA Isolation Kit
Version Model Number64 Tests
Catalog Number3000000000146
Company DUNS561011079
Company Name3D Biomedicine Science & Technology Co., Limited
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973685471349 [Primary]

FDA Product Code

JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

Devices Manufactured by 3D Biomedicine Science & Technology Co., Limited

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06973685471356 - 96A Automated Viral DNA/RNA Isolation Kit2022-06-21 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specim
06973685471189 - ReadiMag FFPE DNA Kit2022-06-03 The ReadiMag FFPE DNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from formalin-f

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