Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, calibrator FDA UDI
- Device Name
- Alinity i BRAHMS PCT Calibrators FDA UDI
- Model / Reference
- 01R1801 FDA UDI
- Description
- Alinity i BRAHMS PCT Calibrators FDA UDI
Identifiers
- Catalog Number
- 01R1801 FDA UDI
- Primary DI / UDI-DI
- 00380740153939 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Procalcitonin (PCT) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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
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, calibrator
Alinity by Abbott Ireland Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Procalcitonin (PCT) IVD, calibrator.
- Diazyme Procalcitonin Calibrator Set — Diazyme Laboratories, Inc.
- ARCHITECT — Abbott · Class I
- ARCHITECT — Abbott · Class I
- DM EXL LOCI BRAHMS PCT Cal Kit — Siemens Healthcare Diagnostics · Class II
- B.R.A.H.M.S PCT sensitive KRYPTOR CAL — B.R.A.H.M.S GmbH · Class II
- TruCal Procalcitonin Calibrator Set — DiaSys Diagnostic Systems GmbH · Class I
- Lumipulse G BRAHMS PCT Calibrator Set — FUJIREBIO INC. · Class II
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
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI 4d5e8212-bf28-408f-b5bd-a5852ec342fc 36 fields · synced May 30, 2026