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ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit

FDA UDI

Class I (US FDA UDI)

by 3D Biomedicine Science & Technology Co., Limited

Identity

Trade Name
ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit FDA UDI
Generic Name
Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name
The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. FDA UDI
Model / Reference
64Tests FDA UDI
Description
The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. FDA UDI

Identifiers

Catalog Number
3103010040 FDA UDI
Primary DI / UDI-DI
06973685471035 FDA UDI
FDA Product Code
JJH FDA UDI
GMDN Term
Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2310 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit by 3D Biomedicine Science & Technology Co., Limited — Class I — FDA UDI — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3D Biomedicine Science & Technology Co., Limited

Sources (1)

  • FDA UDI 96492ef8-9206-4dc3-9094-e9831165c44d 35 fields · synced May 31, 2026