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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 5 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paper Wasp, Polistes spp. | I4 | FDA UDI | Class I | Unknown |
| Peanut | F013 | FDA UDI | Class II | Unknown |
| NOVEOS Cow's Milk, Bos taurus | F002 | FDA UDI | Class II | Active |
| Melon, Honeydew, Cucumis melo | F87 | FDA UDI | Class I | Unknown |
| Papaya, Carica papaya | F293 | FDA UDI | Class I | Unknown |
| White Bean | F15 | FDA UDI | Class I | Unknown |
| Plum, Prunus domestica | F255 | FDA UDI | Class I | Unknown |
| Eggplant, Solanum melongena | F262 | FDA UDI | Class I | Unknown |
| Brome Grass Bromus inermis | G011 | FDA UDI | Class II | Unknown |
| Ciprofloxacin | C307 | FDA UDI | Class I | Unknown |
| Sycamore Platanus occidentalis | T061 | FDA UDI | Class II | Unknown |
| Ragweed, Giant Ambrosia trifida | W003 | FDA UDI | Class II | Unknown |
| Hickory, White, Carya alba | T41 | FDA UDI | Class I | Unknown |
| NOVEOS IgE Negative Control Pack | 63155Z | FDA UDI | Class II | Active |
| Oxeye Daisy Chrysanth. leucanthemum | W007 | FDA UDI | Class II | Unknown |
| NOVEOS Cat Dander, Felis domesticus | E001 | FDA UDI | Class II | Active |
| NOVEOS Mountain Juniper, Juniper sabinoides | T006 | FDA UDI | Class II | Active |
| Whey | F236 | FDA UDI | Class I | Unknown |
| NOVEOS Russian Thistle, Salsola kali | W011 | FDA UDI | Class II | Active |
| Elm, Chinese/Siberian, Ulmus pumila | T38 | FDA UDI | Class I | Unknown |
| Aspergillus versicolor | M19 | FDA UDI | Class I | Unknown |
| Lenscale, Atriplex Ientiformis | W15 | FDA UDI | Class I | Unknown |
| Mulberry, Red, Morus rubra | T71 | FDA UDI | Class I | Unknown |
| Stachybotrys chartarum | M209 | FDA UDI | Class I | Unknown |
| NOVEOS Common Pigweed, Amaranthus retroflexus | W014 | FDA UDI | Class II | Active |
| Foxtail, Meadow Alopecurus pratensis | G016 | FDA UDI | Class II | Unknown |
| Cat Hair/Dander (Std.) | E001 | FDA UDI | Class II | Unknown |
| Wine, Red | F339 | FDA UDI | Class I | Unknown |
| Barley Hordeum vulgare | F006 | FDA UDI | Class II | Unknown |
| Black Pepper, Piper nigrum | F280 | FDA UDI | Class I | Unknown |
| Sage, Salvia officinalis | F219 | FDA UDI | Class I | Unknown |
| HYTEC Penicillium notatum | M001 | FDA UDI | Class I | Unknown |
| Autostat II Anti-Thyroglobulin | FGA03 | FDA UDI | Class II | Unknown |
| NOVEOS Wall Pellitory, Parietaria officinalis | W019 | FDA UDI | Class II | Active |
| Apricot, Prunus armeniaca | F237 | FDA UDI | Class I | Unknown |
| NOVEOS Cocksfoot, Dactylis glomerata | G003 | FDA UDI | Class II | Active |
| Sodium Nitrite | C711 | FDA UDI | Class I | Unknown |
| Autostat II Anti-Sm | FGA31 | FDA UDI | Class II | Unknown |
| Cedar, Mountain (Savin) Juniperus sabinoides (syn. Sabina, ashei) | T006 | FDA UDI | Class II | Unknown |
| Rye | F005 | FDA UDI | Class II | Unknown |
| Autostat II Anti-Cardiolipin IgG | FGA15 | FDA UDI | Class II | Unknown |
| Chickpea, Cicer arietinus | F309 | FDA UDI | Class I | Unknown |
| Botrytis cinerea | M7 | FDA UDI | Class I | Unknown |
| Autostat II Anti-Jo-1 | FGA33 | FDA UDI | Class II | Unknown |
| Timothy Grass Phleum pratense | G006 | FDA UDI | Class II | Unknown |
| NOVEOS Sweet Vernal Grass, Anthoxanthum odoratum | G001 | FDA UDI | Class II | Active |
| House Dust Mite D.pteronyssinus | D001 | FDA UDI | Class II | Unknown |
| NOVEOS Common Silver Birch, Betula verrucosa | T003 | FDA UDI | Class II | Active |
| Horse Dander | E003 | FDA UDI | Class II | Unknown |
| MCS Specific/Total IgE Conjugate | 308174 | FDA UDI | Class II | 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. |