Identity
- Trade Name
- Ca Reagent Kit FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Calcium Reagent Kit for use with EasyRA Analyzers FDA UDI
- Model / Reference
- 10210-4 FDA UDI
- Description
- Calcium Reagent Kit for use with EasyRA Analyzers FDA UDI
Identifiers
- Catalog Number
- 10210-4 FDA UDI
- Primary DI / UDI-DI
- 00386100002060 FDA UDI
- 510(k) Number
- K072249 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
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
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
Yes
FDA UDI
Category: Calcium (Ca2+) IVD, kit, spectrophotometry
Ca Reagent Kit by Medica Corp. — 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
- Sirrus® Calcium LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- 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
K072249 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
- Medica Corp.
Sources (1)
- FDA UDI 1daa39d8-2f7a-46fb-b070-5265373ed9ec 37 fields · synced May 30, 2026