Identity
- Trade Name
- MicroVue FDA UDI
- Generic Name
- Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- MicroVue CIC-C1q EIA FDA UDI
- Model / Reference
- CIC-C1q EIA FDA UDI
- Description
- MicroVue CIC-C1q EIA FDA UDI
Identifiers
- Catalog Number
- A001 FDA UDI
- Primary DI / UDI-DI
- 30014613335535 FDA UDI
- FDA Product Code
- DAK FDA UDI
- GMDN Term
- Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5240 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
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: Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)
MicroVue by Quidel Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA).
- Genemed® — Sakura Finetek USA, Inc · Class I
- CIC-C1q ELISA Kit — Bühlmann Laboratories AG · Class II
- Genemed® — Sakura Finetek USA, Inc · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA UDI a9b1ab89-4a65-4494-b134-513a0251867e 36 fields · synced Jun 8, 2026