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HYCOR 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
LinkedIn: —
Facebook: —
Email: [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 7 of 10

Device	Model / Reference	Registries	Class	Status
NOVEOS Mulberry, Morus alba	T070	FDA UDI	Class II	Active
Brazil Nut	F018	FDA UDI	Class II	Unknown
Green Pea, Pisum sativum	F12	FDA UDI	Class I	Unknown
Hytec EIA Kit	74155	FDA UDI	Class II	Unknown
NOVEOS Maple Leaf Sycamore, London Plane, Platanus acerifolia	T011	FDA UDI	Class II	Active
Wine, White	F338	FDA UDI	Class I	Unknown
Alder, Smooth Alnus rugosa (serrulata)	T202	FDA UDI	Class II	Unknown
Bipolaris spicifera	M046	FDA UDI	Class II	Unknown
IgE Reference Discs	74112	FDA UDI	Class II	Unknown
NOVEOS IgE Positive Control Pack	63150	FDA UDI	Class II	Active
Lettuce, Lactuca sativa	F215	FDA UDI	Class I	Unknown
Pine, Ponderosa, Pinus ponderosa	T49	FDA UDI	Class I	Unknown
NOVEOS Common Pigweed, Amaranthus retroflexus	W014	FDA UDI	Class II	Active
NOVEOS Cow's Milk, Bos taurus	F002	FDA UDI	Class II	Active
Linseed/Flaxseed	F198	FDA UDI	Class I	Unknown
Thistle, Russian Salsola kali	W011	FDA UDI	Class II	Unknown
[email protected]	M001	FDA UDI	Class II	Unknown
Rice	F009	FDA UDI	Class II	Unknown
Alternaria tenuis (alternata)	M006	FDA UDI	Class II	Unknown
Sesame Seed (Bruised Grain)	F010	FDA UDI	Class II	Unknown
Mackerel, Scomber japonicus	F50	FDA UDI	Class I	Unknown
Cranberry, Vaccinium macrocarpon	F177	FDA UDI	Class I	Unknown
Paprika, Capsicum annuum	F218	FDA UDI	Class I	Unknown
Hytec	Maple/Box Elder	FDA UDI	Class II	Unknown
Fusarium culmorum	M18	FDA UDI	Class I	Unknown
Safflower Seed, Carthamus tinctorius	F229	FDA UDI	Class I	Unknown
Lima Bean, Phaseolus limensis	F182	FDA UDI	Class I	Unknown
Cottonwood Tree Populus deltoides	T014	FDA UDI	Class II	Unknown
Sweet Chestnut, Castanea sativa	F299	FDA UDI	Class I	Unknown
Halibut, Hippoglossus hippoglossus	F303	FDA UDI	Class I	Unknown
NOVEOS IgE Calibrator Antibody Pack	63180Z	FDA UDI	Class II	Active
Specific IgE calibrator set	74119	FDA UDI	Class II	Unknown
Autostat II Anti-Gliadin IgG	FGA19	FDA UDI	Class II	Unknown
Egg White	F001	FDA UDI	Class II	Unknown
NOVEOS House Dust - Greer	H001	FDA UDI	Class II	Active
NOVEOS Bahia Grass, Paspalum notatum	G017	FDA UDI	Class II	Active
Kidney Bean (Red Bean), Phaseolus vulgaris	F287	FDA UDI	Class I	Unknown
NOVEOS Oak, Quercus alba	T007	FDA UDI	Class II	Active
NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)	K260059	FDA 510(k)	Class II	Active
NOVEOS Diluent A Kit	K332020-2	FDA UDI	Class II	Active
NOVEOS Olive Tree, Olea europaea	T009	FDA UDI	Class II	Active
Mango, Mangifera indica	F91	FDA UDI	Class I	Unknown
Saffron	F325	FDA UDI	Class I	Unknown
Wheat Pollen, Cultivated Triticum aestivum	G015	FDA UDI	Class II	Unknown
Clam, Mercenaria mercenaria	F207	FDA UDI	Class I	Unknown
Pork	F026	FDA UDI	Class II	Unknown
Zucchini, Cucurbita pepo	F118	FDA UDI	Class I	Unknown
NOVEOS Kentucky Blue Grass, Poa pratensis	G008	FDA UDI	Class II	Active
Corn	F008	FDA UDI	Class II	Unknown
Sunflower Seed	F183	FDA UDI	Class I	Unknown

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.