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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 8 of 10

Device	Model / Reference	Registries	Class	Status
Cladosporium herbarum	M002	FDA UDI	Class II	Unknown
Nutmeg, Myristica fragrans	F282	FDA UDI	Class I	Unknown
Coffee, Coffea spp.	F221	FDA UDI	Class I	Unknown
Ash, White F. americana	T015	FDA UDI	Class II	Unknown
Ginger, Zingiber officinale	F270	FDA UDI	Class I	Unknown
Bermuda Grass Smut, Ustilago cynodontis	M213	FDA UDI	Class I	Unknown
Trichoderma viride	M15	FDA UDI	Class I	Unknown
NOVEOS House Dust Mite, Dermatophagoides farinae	D002	FDA UDI	Class II	Active
Phoma betae	M013	FDA UDI	Class II	Unknown
Beech, American Fagus grandifolia (syn. americana)	T005	FDA UDI	Class II	Unknown
Buckwheat, Fagopyrum esculentum	F11	FDA UDI	Class I	Unknown
Curry	F281	FDA UDI	Class I	Unknown
NOVEOS Mountain Juniper, Juniper sabinoides	T006	FDA UDI	Class II	Active
HYTEC Blackberry, Rubus fruitcosus	F211	FDA UDI	Class I	Unknown
Raspberry, Rubus idaeus	F22	FDA UDI	Class I	Unknown
Autostat II Anti-Gliadin IgA	FGA20	FDA UDI	Class II	Unknown
Wheat Smut, Ustilago tritici	M201	FDA UDI	Class I	Unknown
NOVEOS Aspergillus fumigatus	M003	FDA UDI	Class II	Active
Cumin, Cuminum cyminum	F265	FDA UDI	Class I	Unknown
Acremonium kiliense, syn. Acremonium strictum	M202	FDA UDI	Class I	Unknown
Cotton Linters (Untreated)	O1	FDA UDI	Class I	Unknown
Hackberry, Celtis occidentalis	T44	FDA UDI	Class I	Unknown
Bluegrass, Kentucky/June Poa pratensis	G008	FDA UDI	Class II	Unknown
Crab	F024	FDA UDI	Class II	Unknown
Pumpkin/ Summer Squash, Cucurbita pepo	F225	FDA UDI	Class I	Unknown
NOVEOS Pecan, Hickory, Carya illinoinensis Capture Reagent Pack	T022	FDA UDI	Class II	Active
NOVEOS Elm, Ulmus americana	T008	FDA UDI	Class II	Active
Autostat II Anti-MPO	FGA12	FDA UDI	Class II	Unknown
NOVEOS Conjugate IgE	K332030-2	FDA UDI	Class II	Active
NOVEOS Maple Leaf Sycamore, London Plane, Platanus acerifolia	T011	FDA UDI	Class II	Active
NOVEOS Lamb's Quarters, Goosefoot, Chenopodium album	W010	FDA UDI	Class II	Active
Goat Milk	F300	FDA UDI	Class I	Unknown
Autostat II Anti-Sm/RNP	FGA32	FDA UDI	Class II	Unknown
Specific Ige Control Kit	71207	FDA UDI	Class II	Unknown
Chili Pepper, Capsicum frutescens	F279	FDA UDI	Class I	Unknown
Grapefruit, Citrus paradisi	F209	FDA UDI	Class I	Unknown
Bovine Gelatin	F340	FDA UDI	Class I	Unknown
Watermelon, Citrullus vulgaris	F29	FDA UDI	Class I	Unknown
NOVEOS Maple Box Elder, Acer negundo	T001	FDA UDI	Class II	Active
NOVEOS Rye Grass, Lolium perenne	G005	FDA UDI	Class II	Active
NOVEOS Gray Alder, Alnus incana	T002	FDA UDI	Class II	Active
Autostat II Anti-Cardiolipin IgM	FGA16	FDA UDI	Class II	Unknown
NOVEOS® Immunoassay System	63000	EUDAMEDFDA UDI	Class A	Active
Ventrex Allergen Disc	K924209	FDA 510(k)	Class II	Active
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense	K200825	FDA 510(k)	Class II	Active
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz	K242531	FDA 510(k)	Class II	Active
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)	K252493	FDA 510(k)	Class II	Active
Hy-Tec Automated Eia System	K941278	FDA 510(k)	Class II	Active
Ventrex Allergen Disc	K922538	FDA 510(k)	Class II	Active
Hycor Accupinch Cocaine Test	K896937	FDA 510(k)	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.