Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 1 x 750 mL, 1 x 250 mL. FDA UDI
- Model / Reference
- C7548-1L FDA UDI
- Description
- Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 1 x 750 mL, 1 x 250 mL. FDA UDI
Identifiers
- Catalog Number
- C7548-1L FDA UDI
- Primary DI / UDI-DI
- 00811727014474 FDA UDI
- 510(k) Number
- K050283 FDA UDI
- FDA Product Code
- JFY FDA UDI
- GMDN Term
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Creatinine IVD, kit, enzyme spectrophotometry
Pointe Scientific, Inc. 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
K050283 also covers:
- Creatinine Enzymatic — POINTE SCIENTIFIC, INC.
- Pointe Creatinine Enzymatic on BS480 — POINTE SCIENTIFIC, INC.
- Pointe Creatinine, Enzymatic Reagent — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Creatinine Enzymatic — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Creatinine Enzymatic — 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 2367fca5-6c6b-49f1-8707-e9d570ca5459 37 fields · synced Jun 1, 2026