Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Creatine Kinase Reagent, for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers. Size: 2 x 100mL, 2 x 25mL FDA UDI
- Model / Reference
- HC922-250 FDA UDI
- Description
- Creatine Kinase Reagent, for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers. Size: 2 x 100mL, 2 x 25mL FDA UDI
Identifiers
- Catalog Number
- HC922-250 FDA UDI
- Primary DI / UDI-DI
- 00811727012661 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 Scientific, Inc. 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.
- Creatine Kinase liquid, acc. to IFCC — Roche Diagnostics Corp. · Class II
- Sirrus® CK Liqui-UV® — STANBIO LABORATORY, L.P. · Class II
- Atellica CH CK_L — Siemens Healthcare Diagnostics · Class II
- Creatine Kinase — Roche Diagnostics Corp. · Class II
- CK Liqui-UV® — STANBIO LABORATORY, L.P. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- 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 Creatine Kinase for BS480 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI a8bb8365-ae40-43a7-b106-003d8e5e1236 37 fields · synced May 30, 2026