Identity
- Trade Name
- Yumizen C1200 Immunoglobulin M FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- 1300023884 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230007365 FDA UDI
- 510(k) Number
- K193525 FDA UDI
- FDA Product Code
- DFT FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 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: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Yumizen C1200 Immunoglobulin M by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry.
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Cleared under the same submission
K193525 also covers:
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 44a37c3a-091a-4fa4-9cdb-fd195bde469c 33 fields · synced Jun 8, 2026