Identity
- Trade Name
- CalSet PTH FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, calibrator FDA UDI
- Model / Reference
- 08243875190 FDA UDI
Identifiers
- Catalog Number
- 08243875190 FDA UDI
- Primary DI / UDI-DI
- 07613336147672 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Parathyroid hormone (PTH) 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
Yes
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
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: Parathyroid hormone (PTH) IVD, calibrator
CalSet PTH by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Parathyroid hormone (PTH) IVD, calibrator.
- ADVIA Centaur® iPTH Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- Alinity — Abbott · Class II
- IDS-iSYS Intact PTH Calibration Verifiers — Immunodiagnostic Systems , Ltd. · Class I
- ADVIA Centaur® Systems iPTH Calibrator — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Systems iPTH Calibrator — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® Systems iPTH Calibrator — Siemens Healthcare Diagnostics · Class II
- CalSet PTH STAT — Roche Diagnostics Corp. · Class I
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 |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI b49f40bf-b2a7-4bf3-b3b6-0b8b08fcf05d 34 fields · synced May 30, 2026