MicroVue PTH EIA
by Quidel Corp.
MicroVue PTH EIA (8044) is a Class II device made by Quidel Corp., listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613333944), not in commercial distribution (GUDID) as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613333944 | Date15 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 30014613333944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- MicroVue
- Generic name
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- PTH EIA, 8044
- Primary DI / UDI-DI
- 30014613333944
- FDA product code
- CEW
- GMDN term
- Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 862.1545
- GUDID distribution status
- Not in Commercial Distribution
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Other devices filed under FDA product code CEW (RADIOIMMUNOASSAY, PARATHYROID HORMONE).
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