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Linearity FD Procalcitonin for Siemens Atellica
FDA UDIIdentity
- Trade Name
- Linearity FD Procalcitonin for Siemens Atellica FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, control FDA UDI
- Model / Reference
- K814M-5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B085K814M50 FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, control FDA UDI
Classification
- 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
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: Procalcitonin (PCT) IVD, control
Linearity FD Procalcitonin for Siemens Atellica by Aalto Scientific, Ltd. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Procalcitonin (PCT) IVD, control.
- LIAISON Controls BRAHMS PCT II GEN — Diasorin Inc.
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM BRAHMS PCT QC Kit — Siemens Healthcare Diagnostics · Class I
- Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
- Atellica IM PCT QC — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- LIAISON BRAHMS PCT II GEN Verifiers — Diasorin Inc.
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
- Aalto Scientific, Ltd.
Sources (1)
- FDA UDI 4ceec1d1-0cf4-415b-989b-2e2f1bccc446 32 fields · synced May 30, 2026