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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 4 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NOVEOS Egg White, Gallus gallus | F001 | FDA UDI | Class II | Active |
| Filbert (Hazelnut) | F017 | FDA UDI | Class II | Unknown |
| Grape, Vitis sp | F259 | FDA UDI | Class I | Unknown |
| Green Bell Pepper, Capsicum annuum | F152 | FDA UDI | Class I | Unknown |
| Mosquito, Aedes communis | I71 | FDA UDI | Class I | Unknown |
| NOVEOS Oak, Quercus alba | T007 | FDA UDI | Class II | Active |
| Red Top | G009 | FDA UDI | Class II | Unknown |
| Almond | F020 | FDA UDI | Class II | Unknown |
| Aspergillus fumigatus | M003 | FDA UDI | Class II | Unknown |
| Vernal Grass, Sweet Anthoxanthum odoratum | G001 | FDA UDI | Class II | Unknown |
| Autostat II Anti-Tissue Transglutaminase IgA | FGA25 | FDA UDI | Class II | Unknown |
| Maple Syrup | F377 | FDA UDI | Class I | Unknown |
| Velvet Grass Holcus lanatus | G013 | FDA UDI | Class II | Unknown |
| Mugwort Artemisia vulgaris | W006 | FDA UDI | Class II | Unknown |
| Fusarium moniliforme | M009 | FDA UDI | Class II | Unknown |
| Alfalfa, Medicago sativa | W45 | FDA UDI | Class I | Unknown |
| Cauliflower, Brassica oleracea var. botrytis | F291 | FDA UDI | Class I | Unknown |
| IgE Extended Calibrator Set | 74129 | FDA UDI | Class II | Unknown |
| NOVEOS Fluo Beads | K332065-2Z | FDA UDI | Class II | Active |
| NOVEOS Common Ragweed, Ambrosia artemisiifolia | W001 | FDA UDI | Class II | Active |
| Mucor racemosus | M004 | FDA UDI | Class II | Unknown |
| Pear, Pyrus communis | F94 | FDA UDI | Class I | Unknown |
| Juniper, One Seed, Juniperus monosperma | T47 | FDA UDI | Class I | Unknown |
| Yogurt | F360 | FDA UDI | Class I | Unknown |
| Sheep Sorrel, Red Rumex acetosella | W18 | FDA UDI | Class I | Unknown |
| Fusarium oxysporum | M049 | FDA UDI | Class II | Unknown |
| Cefalexin | C309 | FDA UDI | Class I | Unknown |
| NOVEOS Walnut, Juglans californica | T010 | FDA UDI | Class II | Active |
| Cladosporium cladosporioides | M32 | FDA UDI | Class I | Unknown |
| NOVEOS Common Ragweed, Ambrosia artemisiifolia | W001 | FDA UDI | Class II | Active |
| Mouse Epithelium | E71 | FDA UDI | Class I | Unknown |
| Rye Grass, Perennial Lolium perenne | G005 | FDA UDI | Class II | Unknown |
| NOVEOS House Dust Mite, Dermatophagoides pteronyssinus | D001 | FDA UDI | Class II | Active |
| Duck | F157 | FDA UDI | Class I | Unknown |
| Salmon, Salmo salar | F41 | FDA UDI | Class I | Unknown |
| Stemphylium botryosum | M010 | FDA UDI | Class II | Unknown |
| Autostat II Anti-B2-Glycoprotein I IgA | FGA24 | FDA UDI | Class II | Unknown |
| NOVEOS Redtop, Bentgrass, Agrostis stolonifera | G009 | FDA UDI | Class II | Active |
| NOVEOS Russian Thistle, Salsola kali | W011 | FDA UDI | Class II | Active |
| Autostat II Anti-SS-A/Ro | FGA29 | FDA UDI | Class II | Unknown |
| Autostat II Anti-PR 3 | FGA11 | FDA UDI | Class II | Unknown |
| NOVEOS English Plantain, Plantago lanceolata | W009 | FDA UDI | Class II | Active |
| NOVEOS Maple Box Elder, Acer negundo | T001 | FDA UDI | Class II | Active |
| Lemon, Citrus limon | F208 | FDA UDI | Class I | Unknown |
| Cod | F003 | FDA UDI | Class II | Unknown |
| Autostat II IgG Rheumatoid Factor | FGA07 | FDA UDI | Class II | Unknown |
| Substrate Diluent | 308050 | FDA UDI | Class II | Unknown |
| Cayenne Pepper, Capsicum frutescens | F19 | FDA UDI | Class I | Unknown |
| Marsh Elder, Rough Iva ciliata | W016 | FDA UDI | Class II | Unknown |
| Sweet Gum, Liquidambar styraciflua | T211 | FDA UDI | Class I | Unknown |
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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. |