Identity
- Trade Name
- Bio30+ Physio W/O A/S HR FDA UDI
- Generic Name
- Amino acid analyser IVD FDA UDI
- Device Name
- Ion exchange chromatography analyzer sold with lithium high resolution column. FDA UDI
- Model / Reference
- 80-6000-58 FDA UDI
- Description
- Ion exchange chromatography analyzer sold with lithium high resolution column. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056336800284 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Amino acid analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Amino acid analyser IVD
Bio30+ Physio W/O A/S HR by Biochrom Limited — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Amino acid analyser IVD.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biochrom Limited
Sources (2)
- FDA UDI 3464848a-c899-450f-bf7f-baf37f30c181 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026