Identity
- Trade Name
- Yumizen C1200 Level 2 CRPhs Control FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Model / Reference
- 1300071248 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230009291 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- C-reactive protein (CRP) 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: C-reactive protein (CRP) IVD, control
Yumizen C1200 Level 2 CRPhs Control by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as C-reactive protein (CRP) IVD, control.
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- Diazyme — Diazyme Laboratories, Inc.
- POINTE SCIENTIFIC CRP Control Set — POINTE SCIENTIFIC, INC. · Class II
- IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- DImension Vista® High Sensitivity CRP Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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 |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI 3b31de9d-feb3-4ded-a1c1-e66f1b8dd98d 32 fields · synced May 30, 2026