Identity
- Trade Name
- EchoLUTION Viral RNA/DNA Kit (8 x 48) FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Model / Reference
- 012-051-008-Dx FDA UDI
Identifiers
- Catalog Number
- 012-051-008-Dx FDA UDI
- Primary DI / UDI-DI
- 04260759850189 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
EchoLUTION Viral RNA/DNA Kit (8 x 48) by BioEcho Life Sciences GmbH — Class I — 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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- HPLC column — Immundiagnostik AG · Class A
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- 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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- BioEcho Life Sciences GmbH
Sources (1)
- FDA UDI df4b4409-3242-4d0b-b591-a60bd1a78902 33 fields · synced May 31, 2026