Identity
- Trade Name
- MicroVue FDA UDI
- Generic Name
- Complement component C1 inhibitor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- MicroVue C1-Inhibitor Plus EIA FDA UDI
- Model / Reference
- C1-Inhibitor FDA UDI
- Description
- MicroVue C1-Inhibitor Plus EIA FDA UDI
Identifiers
- Catalog Number
- A037 FDA UDI
- Primary DI / UDI-DI
- 30014613335580 FDA UDI
- FDA Product Code
- DBA FDA UDI
- GMDN Term
- Complement component C1 inhibitor IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5250 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: Complement component C1 inhibitor IVD, kit, enzyme immunoassay (EIA)
MicroVue by Quidel Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6db759ed-b49f-4b2d-afe3-ffe8ad9b9c74 36 fields · synced Jun 1, 2026