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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 6 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NOVEOS Carrot, Daucus carota | F031 | FDA UDI | Class II | Active |
| Formaldehyde | K80 | FDA UDI | Class I | Unknown |
| Total IgE Sample Diluent | 309046 | FDA UDI | Class II | Unknown |
| Bing Cherry, Prunus avium | F242 | FDA UDI | Class I | Unknown |
| Plantain, English Plantago lanceolata | W009 | FDA UDI | Class II | Unknown |
| NOVEOS Sheep Sorrel, Rumex acetosella | W018 | FDA UDI | Class II | Active |
| Oak, White | T007 | FDA UDI | Class II | Unknown |
| Autostat II ENA-6 Screen | FGA14 | FDA UDI | Class II | Unknown |
| NOVEOS White Ash, Fraxinus americana | T015 | FDA UDI | Class II | Active |
| NOVEOS Aspergillus fumigatus | M003 | FDA UDI | Class II | Active |
| Cypress, White Bald, Taxodium distichum | T37 | FDA UDI | Class I | Unknown |
| Oat Pollen, Cultivated Avena sativa | G014 | FDA UDI | Class II | Unknown |
| NOVEOS Johnson Grass, Sorghum halepense | G010 | FDA UDI | Class II | Active |
| Malt | F90 | FDA UDI | Class I | Unknown |
| Cheddar Cheese | F081 | FDA UDI | Class II | Unknown |
| Brussels Sprouts, Brassica oleracea var. gennifera | F217 | FDA UDI | Class I | Unknown |
| Green Bean, Phaseolus vulgaris | F315 | FDA UDI | Class I | Unknown |
| Oyster, Ostrea sp. | F290 | FDA UDI | Class I | Unknown |
| NOVEOS Fluo Beads | K332065-2 | FDA UDI | Class II | Active |
| Fire Ant, Solenopsis invicta | I70 | FDA UDI | Class I | Unknown |
| Elm, American Ulmus americana | T008 | FDA UDI | N/A | Unknown |
| Goat's Cheese | F139 | FDA UDI | Class I | Unknown |
| Bermuda Grass Cynodon dactylon | G002 | FDA UDI | Class II | Unknown |
| Hytec | Specific IgE Reference Disc | FDA UDI | Class II | Unknown |
| Basil, Ocimum basilicum | F269 | FDA UDI | Class I | Unknown |
| PnPP Tablets | 308053 | FDA UDI | Class II | Unknown |
| Thyme, Thymus vulgaris | F273 | FDA UDI | Class I | Unknown |
| Aspen, Quaking, Populus tremoloides | T228 | FDA UDI | Class I | Unknown |
| Parmesan Cheese | F67 | FDA UDI | Class I | Unknown |
| Dandelion Taraxacum officinale | W008 | FDA UDI | Class II | Unknown |
| Hazelnut Corylus avellana | T004 | FDA UDI | Class II | Unknown |
| Orris Root, Iris floretina | K89 | FDA UDI | Class I | Unknown |
| NOVEOS IgE Calibrator Set | 63125 | FDA UDI | Class II | Active |
| Hytec | MCS Specific Total IgE Conjugate | FDA UDI | Class II | Unknown |
| NOVEOS Cottonwood Tree, Populus deltoides | T014 | FDA UDI | Class II | Active |
| NOVEOS Timothy Grass, Phleum pratense | G006 | FDA UDI | Class II | Active |
| Candida albicans | M005 | FDA UDI | Class II | Unknown |
| IgE Conjugate MCS | 308174 | FDA UDI | Class II | Unknown |
| Hytec Specific/Total IgE Control | 74120 | FDA UDI | Class II | Unknown |
| NOVEOS Alternaria alternata | M006 | FDA UDI | Class II | Active |
| Brewer's Yeast, Saccharomyces cerevisiae | F155 | FDA UDI | Class I | Unknown |
| Potato, White | F035 | FDA UDI | Class II | Unknown |
| Oak, Live/Virginia Quercus virginiana | T103 | FDA UDI | Class II | Unknown |
| Willow, Salix caprea | T12 | FDA UDI | Class I | Unknown |
| Tuna | F040 | FDA UDI | Class II | Unknown |
| Soy Milk, Glycine max | F200 | FDA UDI | Class I | Unknown |
| Dog Epithelium | E002 | FDA UDI | Class II | Unknown |
| Cane Sugar, Saccharum officinarum | F21 | FDA UDI | Class I | Unknown |
| Chaetomium globosum | M208 | FDA UDI | Class I | Unknown |
| NOVEOS Johnson Grass, Sorghum halepense | G010 | FDA UDI | Class II | Active |
Related Companies
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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. |