← Back to catalogue
Phadia Information Data Manager Software Package
FDA UDIClass II (US FDA UDI)
by Phadia GmbH
Identity
- Trade Name
- Phadia Information Data Manager Software Package FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Phadia Information Data Manager Software Package FDA UDI
- Model / Reference
- 12-3801-11 FDA UDI
- Description
- Phadia Information Data Manager Software Package FDA UDI
Identifiers
- Catalog Number
- 12-3801-11 FDA UDI
- Primary DI / UDI-DI
- 07333066001012 FDA UDI
- 510(k) Number
- K051218 FDA UDI
- FDA Product Code
- DHB FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory instrument/analyser application software IVD
Phadia Information Data Manager Software Package by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory instrument/analyser application software IVD.
- Alinity — Abbott · Class I
- Navios Analysis Software — BECKMAN COULTER IRELAND INC. · Class II
- Alinity — Abbott · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- RealTime — Abbott Molecular · Class II
- Alinity — Abbott · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott · Class I
Cleared under the same submission
K051218 also covers:
- ImmunoCAP Allergen f57, Japanese millet — Phadia GmbH
- ImmunoCAP Allergen fx9, Food — Phadia GmbH
- ImmunoCAP Allergen i72, Green nimitti — Phadia GmbH
- ImmunoCAP Allergen k74, Silk — Phadia GmbH
- ImmunoCAP Allergen w1, Common ragweed — Phadia GmbH
- ImmunoCAP Specific IgE Calibrators 0-100 — Phadia GmbH
- Phadia 100 — Phadia GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI c0f6aa52-6673-47ca-98ff-16f3f77d7403 36 fields · synced Jun 6, 2026