Identity
- Trade Name
- RADI 192 Bacteria DNA/RNA Extraction Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Bacterial DNA and RNA from urine, stool, swab and pre-treated sputum (NaOH, NALC). Automated nucleic acid extraction can be performed with this kit by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is intended to be use by a laboratory professional. FDA UDI
- Model / Reference
- OP005 FDA UDI
- Description
- The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Bacterial DNA and RNA from urine, stool, swab and pre-treated sputum (NaOH, NALC). Automated nucleic acid extraction can be performed with this kit by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is intended to be use by a laboratory professional. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800204300522 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 Bacteria DNA/RNA Extraction Kit by KH Medical Co., Ltd. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- KH Medical Co., Ltd.
Sources (1)
- FDA UDI 8b6d5156-dc6e-4251-94d3-6bb816612072 33 fields · synced May 30, 2026