Identity
- Trade Name
- ABBOTT PRISM FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL FDA UDI
- Model / Reference
- 6A36-34 FDA UDI
- Description
- ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL FDA UDI
Identifiers
- Catalog Number
- 06A3634 FDA UDI
- Primary DI / UDI-DI
- 00380740008574 FDA UDI
- FDA Product Code
- MZA FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- N FDA UDI
- 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
No
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
No
FDA UDI
Abbott Prism by Abbott Laboratories, Inc. — Class N — 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 | Class N | Pending data |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA UDI fd36d038-71b6-4c69-b862-d5da84c413aa 36 fields · synced May 30, 2026