Identity
- Trade Name
- Pointe Scientific CK-MB FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only. FDA UDI
- Model / Reference
- C7563-90 FDA UDI
- Description
- Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx Only. FDA UDI
Identifiers
- Catalog Number
- C7563-90 FDA UDI
- Primary DI / UDI-DI
- 00811727018649 FDA UDI
- 510(k) Number
- K942958 FDA UDI
- FDA Product Code
- JHW FDA UDI
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry
Pointe Scientific CK-MB 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
K942958 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- POINTE SCIENTIFIC CK-MB — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC CK-MB — POINTE SCIENTIFIC, INC.
- POINTE SCIENTIFIC CK-MB — POINTE SCIENTIFIC, INC.
- Pointe Scientific CK-MB — 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 71d0a1ce-34d0-4bd3-bada-f64069e3ef4a 37 fields · synced May 30, 2026