Identity
- Trade Name
- RADI 192 Whole Blood DNA/RNA Extraction Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer. FDA UDI
- Model / Reference
- OP003 FDA UDI
- Description
- This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204300508 FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
RADI 192 Whole Blood DNA/RNA Extraction Kit by KH Medical Co., Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
Sources (1)
- FDA UDI 8b4a778c-1f25-4e15-816e-e5f7995ffa88 33 fields · synced Jun 8, 2026