96A Automated Viral DNA/RNA Isolation Kit 3000000000493

GUDID 06973685471394

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.

3D Biomedicine Science & Technology Co., Limited

Nucleic acid extraction/isolation kit IVD
Primary Device ID06973685471394
NIH Device Record Key14900b2b-fed0-4f52-91ae-a6f68c30fa62
Commercial Distribution StatusIn Commercial Distribution
Brand Name96A Automated Viral DNA/RNA Isolation Kit
Version Model Number500 Tests
Catalog Number3000000000493
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS106973685471394 [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 Date2022-10-10
Device Publish Date2022-10-02

On-Brand Devices [96A Automated Viral DNA/RNA Isolation Kit]

0697368547135696A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DN
0697368547139496A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DN

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.