Identity
- Trade Name
- Pointe Calcium Arsenazo for BS480 FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or heparinized plasma. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 14-C7529-360 FDA UDI
- Description
- Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or heparinized plasma. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 14-C7529-360 FDA UDI
- Primary DI / UDI-DI
- 00811727015754 FDA UDI
- 510(k) Number
- K921625 FDA UDI
- FDA Product Code
- CIC 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
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: Calcium (Ca2+) IVD, kit, spectrophotometry
Pointe Calcium Arsenazo for BS480 by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K921625 also covers:
- IDG/Sanzay — IDG/SANZAY Corporation
- 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 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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 897ad798-5794-424a-a6c8-265a45691340 37 fields · synced Jun 8, 2026