Identity
- Trade Name
- Yumizen C1200 Calcium AS FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 1300047910 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230008607 FDA UDI
- 510(k) Number
- K191396 FDA UDI
- FDA Product Code
- CJY FDA UDI
- GMDN Term
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 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
No
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
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: Calcium (Ca2+) IVD, kit, spectrophotometry
Yumizen C1200 Calcium AS by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium (Ca2+) IVD, kit, spectrophotometry.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- ARCHITECT — Abbott · Class II
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- ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) — Siemens Healthcare Diagnostics · Class II
- CALCIUM Assay — Sekisui Diagnostics, LLC · Class II
- CALCIUM (Ca) — Randox Laboratories, Ltd. · Class II
- Calcium Gen2 — Roche Diagnostics Corp. · Class II
- Atellica CH Ca — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K191396 also covers:
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
- Horiba Abx
Sources (1)
- FDA UDI fc4eefbf-d30f-42d2-bb3d-1607d9b6e654 33 fields · synced Jun 8, 2026