Identity
- Trade Name
- Pointe Creatine Kinase for BS480 FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase activity in serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 14-C7522-220 FDA UDI
- Description
- Pointe Creatine Kinase packaged for use on the BS480. 4x40mL, 4x15mL Kit. For the quantitative determination of creatine kinase activity in serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 14-C7522-220 FDA UDI
- Primary DI / UDI-DI
- 00811727015785 FDA UDI
- 510(k) Number
- K972155 FDA UDI
- FDA Product Code
- CGS FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Pointe Creatine Kinase for BS480 by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry.
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- Creatine Kinase liquid, acc. to IFCC — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K972155 also covers:
- CK — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC CK (Liquid) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC CK (Liquid) — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC CK (Liquid) — POINTE SCIENTIFIC, INC.
- Pointe Creatine Kinase Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. CK — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. CK — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Creatine Kinase — 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 370dd4af-7eaa-4feb-bdd2-b9991e572066 37 fields · synced May 30, 2026