Identity
- Trade Name
- ReadiMag Pathogen Nucleic Acid Isolation Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. 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
- 32 Tests FDA UDI
- Description
- The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. 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
- 3000000000359 FDA UDI
- Primary DI / UDI-DI
- 06973685471912 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Nucleic acid extraction/isolation kit IVD
ReadiMag Pathogen Nucleic Acid Isolation Kit by 3D Biomedicine Science & Technology Co., Limited — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
Sources (1)
- FDA UDI 197a12e3-a3f2-476c-9732-1be5f9fd610d 34 fields · synced Jun 8, 2026