Identity
- Trade Name
- Pointe Creatinine Enzymatic on BS480 FDA UDI
- Generic Name
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. FDA UDI
- Model / Reference
- 14-C7548-216 FDA UDI
- Description
- Pointe Creatinine Enzymatic Reagent packaged for use on the BS480. 4x40mL, 4x14mL Kit. For the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. FDA UDI
Identifiers
- Catalog Number
- 14-C7548-216 FDA UDI
- Primary DI / UDI-DI
- 00811727015761 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 Creatinine Enzymatic on BS480 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 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. 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 29a9bc32-17f4-4639-bc58-84a3efa00886 37 fields · synced Jun 1, 2026