Identity
- Trade Name
- Yumizen C1200 Creatinine PAP FDA UDI
- Generic Name
- Creatinine IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Yumizen C1200 Creatinine PAP 1300023844 : R1 ( 4x46 mL ; R2 3x34 mL) 1300023843 : R1 ( 6x35 mL ; R2 6x19 mL) FDA UDI
- Model / Reference
- 1300023844 FDA UDI
- Description
- Yumizen C1200 Creatinine PAP 1300023844 : R1 ( 4x46 mL ; R2 3x34 mL) 1300023843 : R1 ( 6x35 mL ; R2 6x19 mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006962 FDA UDI
- 510(k) Number
- K193649 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yumizen C1200 Creatinine PAP by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CREATININE PAP SL — VITALSCIENTIFIC
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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
- Horiba Abx
Sources (1)
- FDA UDI 4a52aa4c-cde4-4545-acf4-9f80101270c3 34 fields · synced May 31, 2026