Identity
- Trade Name
- Diazyme Procalcitonin Control Set FDA UDI
- Generic Name
- Procalcitonin (PCT) IVD, control FDA UDI
- Model / Reference
- DZ558A-CON FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817089020924 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
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
No
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
Diazyme Procalcitonin Control Set by Diazyme Laboratories, Inc. — 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
- Audit MicroControls Linearity FD Procalcitonin bioMerieux VIDAS and miniVIDAS — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD Procalcitonin for Abbott Systems — Aalto Scientific, Ltd.
- Elecsys PCT CalCheck 5 — Roche Diagnostics Corp. · Class I
- Alinity — Abbott Ireland Diagnostics · Class I
- Atellica IM PCT QC — Siemens Healthcare Diagnostics · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diazyme Laboratories, Inc.
Sources (1)
- FDA UDI f0414ca1-ae0e-4756-8d30-6715a6d45b74 32 fields · synced Jun 9, 2026