Identity
- Trade Name
- DC-CAL Calibrator FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Model / Reference
- SE-035 FDA UDI
Identifiers
- Catalog Number
- SE-035 FDA UDI
- Primary DI / UDI-DI
- 00628063400447 FDA UDI
- 510(k) Number
- K882258 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile 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
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: Multiple-type clinical chemistry analyte profile IVD, calibrator
DC-CAL Calibrator by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type clinical chemistry analyte profile IVD, calibrator.
- VITROS — Ortho-Clinical Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910 — Carolina Liquid Chemistries Corp. · Class II
- no MS ISE Calibrator Direct) — Roche Diagnostics Corp. · Class II
- Dimension Vista CHEM 1 CAL — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 3 CC910 — Carolina Liquid Chemistries Corp. · Class II
- ADVIA® Chemistry ToxAmmonia Cal — Siemens Healthcare Diagnostics · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Alfa Wassermann — Alfa Wassermann, 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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 9df5d529-0310-4fdf-a904-f3ce6d5f2bbe 34 fields · synced Jun 9, 2026