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Sign in to claim this brandHYCOR BIOMEDICAL LLC
United States·US-MF-000031449
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 7272 Chapman Avenue, Garden Grove, CA, United States
- Website
- www.hycorbiomedical.com
- —
- —
- [email protected]
- Phone
- +1 800 382 2527
- PRRC Contact
- Aashrey Kaul
- EUDAMED SRN
- US-MF-000031449
- FDA FEI Number
- 1000125787
- DUNS Number
- 010558476
Catalogue (468)
Page 1 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tree of Heaven Ailanthus altissima | T001 | FDA UDI | Class II | Unknown |
| Rye, Cultivated Secale cereale | G012 | FDA UDI | Class II | Unknown |
| Tubes (9x45mm plastic) | 312500 | FDA UDI | Class II | Unknown |
| NOVEOS Common Silver Birch, Betula verrucosa | T003 | FDA UDI | Class II | Active |
| Autostat II Anti-Scl-70 | FGA34 | FDA UDI | Class II | Unknown |
| Kiwi, Actinidia chinensis | F84 | FDA UDI | Class I | Unknown |
| Wine Vinegar | F336 | FDA UDI | Class I | Unknown |
| NOVEOS Substrate Pack | K33218085-4Z | FDA UDI | Class II | Active |
| NOVEOS Carrot, Daucus carota | F031 | FDA UDI | Class II | Active |
| House dust Mite D. farinae | D002 | FDA UDI | Class II | Unknown |
| NOVEOS Timothy Grass, Phleum pratense | G006 | FDA UDI | Class II | Active |
| NOVEOS Substrate Pack | K33218085-4 | FDA UDI | Class II | Active |
| Pine Nut, Pinus edulis | F253 | FDA UDI | Class I | Unknown |
| Haddock, Melanogrammus aeglefinus | F42 | FDA UDI | Class I | Unknown |
| Latex (U.S.) w/D.I. | K082 | FDA UDI | Class II | Unknown |
| Macadamia Nut, Macadamia spp. | F345 | FDA UDI | Class I | Unknown |
| NOVEOS Alternaria alternata | M006 | FDA UDI | Class II | Active |
| Pistachio Nut, Pistacia vera | F203 | FDA UDI | Class I | Unknown |
| Corn Smut, Ustilago maydis | M215 | FDA UDI | Class I | Unknown |
| Helminthosporium halodes | M008 | FDA UDI | Class II | Unknown |
| NOVEOS Diluent A Kit | K332020-2Z | FDA UDI | Class II | Active |
| Autostat II Anti-ENA-6 Profile | FGA38 | FDA UDI | Class II | Unknown |
| Cow's Milk | F002 | FDA UDI | Class II | Unknown |
| Mushroom, Agaricus hortensis/bisporus | F212 | FDA UDI | Class I | Unknown |
| Hytec Specific IgE Reference Disc 100T MCS | 74112 | FDA UDI | Class II | Unknown |
| NOVEOS Walnut, Juglans californica | T010 | FDA UDI | Class II | Active |
| NOVEOS Gray Alder, Alnus incana | T002 | FDA UDI | Class II | Active |
| Honey | F247 | FDA UDI | Class I | Unknown |
| Wormwood/Sagebrush Artemisia absinthium | W005 | FDA UDI | Class II | Unknown |
| NOVEOS Sweet Vernal Grass, Anthoxanthum odoratum | G001 | FDA UDI | Class II | Active |
| Careless Weed Amaranthus palmeri | W082 | FDA UDI | Class II | Unknown |
| Ragweed, Western Ambrosia psilostachya | W002 | FDA UDI | Class II | Unknown |
| EIA Wash Solution | 308126 | FDA UDI | Class II | Unknown |
| Orange | F033 | FDA UDI | Class II | Unknown |
| Soybean | F014 | FDA UDI | Class II | Unknown |
| NOVEOS IgE Calibrator Set | 63125Z | FDA UDI | Class II | Active |
| NOVEOS White Ash - Fraxinus americana | T015 | FDA UDI | Class II | Active |
| NOVEOS Cuvette Wash Pack | 63190Z | FDA UDI | Class II | Active |
| Quinoa, Chenopodium quinoa | F347 | FDA UDI | Class I | Unknown |
| Fescue, Meadow Festuca elatior | G004 | FDA UDI | Class II | Unknown |
| Wheat | F004 | FDA UDI | Class II | Unknown |
| Lamb's Quarter (Goosefeet) Chenopodium album | W010 | FDA UDI | Class II | Unknown |
| Reed, Common Phragmites communis | G007 | FDA UDI | Class II | Unknown |
| Yellow Hornet, Dolichovespula arenaria | I5 | FDA UDI | Class I | Unknown |
| Lentil, Lens esculenta | F235 | FDA UDI | Class I | Unknown |
| HYTEC Cow Dander | E004 | FDA UDI | Class I | Unknown |
| Orchard Grass Dactylis glomerata | G003 | FDA UDI | Class II | Unknown |
| NOVEOS Rye Grass, Lolium perenne | G005 | FDA UDI | Class II | Active |
| Turkey, Meleagris gallopavo | F284 | FDA UDI | Class I | Unknown |
| NOVEOS Sheep Sorrel, Rumex acetosella | W018 | FDA UDI | Class II | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 25, 2018 | Z-0224-2020 | — | open, classified | Some of the Stop Solution bottles, a caustic solution, have been reported to leak. |
| Mar 19, 2018 | Z-2200-2019 | — | open, classified | Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid. |
| Feb 21, 2018 | Z-2134-2019 | — | completed | Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor. |