Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of calcium concentration in serum or plasma. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- For the quantitative determination of calcium concentration in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- C105 FDA UDI
- Primary DI / UDI-DI
- 00850053916076 FDA UDI
- 510(k) Number
- K921625 FDA UDI
- FDA Product Code
- CIC FDA UDI
- GMDN Term
- Calcium (Ca2+) IVD, reagent 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
No
FDA UDI
Over-the-Counter
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 100 Milliliter FDA UDI
Category: Calcium (Ca2+) IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K921625 also covers:
- Calcium — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Calcium Arsenazo — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Calcium Arsenazo — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Calcium Arsenazo — POINTE SCIENTIFIC, INC.
- Pointe Calcium Arsenazo for BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
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
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 39558e89-60da-4e2b-a910-ad5254c9011e 37 fields · synced Jun 8, 2026