QuickVue+ Mononucleosis Test
by Quidel Corp.
QuickVue+ Mononucleosis Test (20121) is a Class II device made by Quidel Corp., cleared under FDA 510(k) K902510 on 16 Jul 1990 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613201212), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613201212 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK902510 | Date16 Jul 1990 | StatusActive |
Official records
- AccessGUDID record 30014613201212
- FDA 510(k) database K902510
Across registries
- FDA 510(k) K902510 decided 16 Jul 1990 Active
- FDA GUDID UDI-DI 30014613201212 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K902510
- Listed FDA GUDID 30014613201212
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuickVue+
- Generic name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- Mononucleosis Test, 20121
- Primary DI / UDI-DI
- 30014613201212
- 510(k) Number
- FDA product code
- KTN
- GMDN term
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 866.5640
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KTN (SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS).
- MONODEX by Cenogenics Corp.
- DETECTADOT SYSTEM 2000 HETEROPHILE TEST by Gull Laboratories, Inc.
- V-TREND TARGET IM TEST by Texas Immunology, Inc.
- COLOR-MONOGEN by INSTRUMENTATION LABORATORY COMPANY
- ACCUTEX IM LATEX TEST by J.S. Medical Assoc.
- MONOSTICON UNI-DOT by Organon, Inc.
- MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET by Armkel, LLC
- IMMUNOCARD MONO by Meridian Diagnostics, Inc.
- INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST by Ampcor, Inc.
- MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX by Trinity Laboratories, Inc.