Identity
- Trade Name
- ARIES® Extraction Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM). FDA UDI
- Model / Reference
- 50-10026 FDA UDI
- Description
- The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840487100073 FDA UDI
- 510(k) Number
- K160517 FDA UDI
- FDA Product Code
- OOI FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ARIES® Extraction Kit by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K160517 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI cfc501df-0144-403b-bc62-cfff1ade9bfb 37 fields · synced Jun 9, 2026