Identity
- Trade Name
- Pointe Calcium Reagent FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, reagent FDA UDI
- Device Name
- Pointe Calcium Reagent packaged for use on the Mindray BA800. 5 x 66ml R1, 5 x 30ml R2. For the quantitative determination of calcium in serum on Mindray BA-800M analyzers. For in vitro diagnostic use only. Rx Only FDA UDI
- Model / Reference
- 16-HC902-480 FDA UDI
- Description
- Pointe Calcium Reagent packaged for use on the Mindray BA800. 5 x 66ml R1, 5 x 30ml R2. For the quantitative determination of calcium in serum on Mindray BA-800M analyzers. For in vitro diagnostic use only. Rx Only FDA UDI
Identifiers
- Catalog Number
- 16-HC902-480 FDA UDI
- Primary DI / UDI-DI
- 00811727016065 FDA UDI
- 510(k) Number
- K822469 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
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, reagent
Pointe Calcium Reagent 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
K822469 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- POINTE SCIENTIFIC Calcium (2 part) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Calcium (2 part) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC Calcium Standard — POINTE SCIENTIFIC, INC.
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — 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 fbf49a8a-2107-4268-bbe7-e0373bd9a8bd 37 fields · synced Jun 8, 2026