MicroVue Calcitonin EIA
by Quidel Corp.
MicroVue Calcitonin EIA (8043) is a Class II device made by Quidel Corp., listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613333937), 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 | Number30014613333937 | Date15 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 30014613333937
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- MicroVue
- Generic name
- Calcitonin IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- Calcitonin EIA, 8043
- Primary DI / UDI-DI
- 30014613333937
- FDA product code
- JKR
- GMDN term
- Calcitonin IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 862.1140
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code JKR (RADIOIMMUNOASSAY, CALCITONIN).
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- IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL by Diagnostic Products Corp.
- CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) by SCANTIBODIES LABORATORY INC.
- Calcitonin AccuLite CLIA Test System - 96 Wells 9375-300 9375-300A by MONOBIND, INC.
- CALCITONIN RIA KIT by Endocrine Associates, Inc.
- NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT by Quest Diagnostics Nichols Institute
- CALCITONIN KIT MITSUBISHI YUKA by Mitsubishi Yuka America, Inc.