Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Reagent for the quantitative determination of Calcium in serum. 1 x 120 ml FDA UDI
- Model / Reference
- 13-C7503-COL-120 FDA UDI
- Description
- Reagent for the quantitative determination of Calcium in serum. 1 x 120 ml FDA UDI
Identifiers
- Catalog Number
- 13-C7503-COL-120 FDA UDI
- Primary DI / UDI-DI
- 00811727013958 FDA UDI
- 510(k) Number
- K822469 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 Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium (Ca2+) IVD, kit, spectrophotometry.
- 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
- CAROLINA LIQUID CHEMISTRIES CORP.™ CALCIUM REAGENT 88815 — Carolina Liquid Chemistries Corp. · Class II
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 Calcium Reagent — 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.
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 ba0ae6b0-b2ef-4e09-838e-7460f2671cb9 37 fields · synced May 31, 2026