Identity
- Trade Name
- Quantum Blue® Reader FDA UDI
- Generic Name
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
- Model / Reference
- BI-POCTR-ABS FDA UDI
Identifiers
- Primary DI / UDI-DI
- EBUHBIPOCTRABS0 FDA UDI
- GMDN Term
- Photometric/spectroscopic immunoassay analyser IVD FDA UDI
Classification
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Quantum Blue® Reader by Bühlmann Laboratories AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Bühlmann Laboratories AG
Sources (1)
- FDA UDI e28ce1d1-bcfa-4da6-8117-0b04d86b944b 35 fields · synced May 30, 2026