Identity
- Trade Name
- Yumizen C1200 L2 Cystatin C Control FDA UDI
- Generic Name
- Cystatin C IVD, control FDA UDI
- Model / Reference
- 1300023953 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230007945 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cystatin C IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cystatin C IVD, control
Yumizen C1200 L2 Cystatin C Control by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cystatin C IVD, control.
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Cystatin C Controls — Sentinel Ch. Srl · Class I
- CYSTATIN C CONTROL - LEVEL 2 (CYSC CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Cystatin C Control Set Gen.2 — Roche Diagnostics Corp. · Class I
- CYSTATIN C CONTROL - LEVEL 3 (CYSC CONTROL 3) — Randox Laboratories, Ltd. · Class I
- Audit MicroControls Linearity LQ Cystatin C — Aalto Scientific, Ltd.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI 12cb257c-9326-415a-b0c9-62f2034c78c3 32 fields · synced May 30, 2026