Identity
- Trade Name
- RADI PREP PLUS 48 Swab DNA,RNA Extraction Kit FDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Model / Reference
- AP101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204300546 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid sample preparation instrument 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 sample preparation instrument IVD
RADI PREP PLUS 48 Swab DNA, RNA Extraction Kit by KH Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
Sources (1)
- FDA UDI 64433ddb-a664-4ba4-8088-4b15e3601bb8 33 fields · synced Jun 1, 2026