Identity
- Trade Name
- RADI 32 Viral DNA/RNA Extraction KIT FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples collected from vagina, or pharynx using cotton swabs. Automated nucleic acid extraction can be performed by RADI 32 Extractor. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is for use by a laboratory professional. FDA UDI
- Model / Reference
- RADIPREP EUDAMEDOP001 EUDAMEDFDA UDI
- Description
- The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples collected from vagina, or pharynx using cotton swabs. Automated nucleic acid extraction can be performed by RADI 32 Extractor. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is for use by a laboratory professional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204300706 EUDAMEDFDA UDI
- Basic UDI-DI
- 88002043RADIPREPSD EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
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
Op001 by KH Medical Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88002043RADIPREPSD | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000017883
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 1329857d-e114-4dc6-a835-9d1c2b890664 61 fields · synced Jul 9, 2026
- FDA UDI 66389081-8dc0-45cf-bdb5-1a0867e408bd 33 fields · synced May 24, 2026