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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 3 of 10

Device	Model / Reference	Registries	Class	Status
NOVEOS Probe Wash Pack	63170Z	FDA UDI	Class II	Active
NOVEOS IgE Calibrator Set	63145	FDA UDI	Class II	Unknown
Autostat II Anti-SS-B/La	FGA30	FDA UDI	Class II	Unknown
NOVEOS Redtop, Bentgrass, Agrostis stolonifera	G009	FDA UDI	Class II	Active
Cabbage, Brassica oleracea var. capitata	F216	FDA UDI	Class I	Unknown
Tomato	F025	FDA UDI	Class II	Unknown
Autostat II Anti-Gastric Parietal Cell	FGA10	FDA UDI	Class II	Unknown
NOVEOS IgE Calibrator Antibody Pack	63180	FDA UDI	Class II	Active
Raisin, Vitis sp	F179	FDA UDI	Class I	Unknown
NOVEOS English Plantain, Plantago lanceolata	W009	FDA UDI	Class II	Active
Hops, Humulus lupulus	F324	FDA UDI	Class I	Unknown
Autostat II Anti-B2-Glycoprotein I IgG	FGA22	FDA UDI	Class II	Unknown
Pecan Tree Carya illinoinensis	T022	FDA UDI	Class II	Unknown
NOVEOS IgE Common Kit	63140	FDA UDI	Class II	Unknown
Bahia Grass Paspalum notatum	G017	FDA UDI	Class II	Unknown
Autostat II Anti-Cardiolipin Screen	FGA18	FDA UDI	Class II	Unknown
Epicoccum purpurascens	M014	FDA UDI	Class II	Unknown
Lime, Citrus aurantiifolia	F306	FDA UDI	Class I	Unknown
NOVEOS Conjugate IgE	K332030-2Z	FDA UDI	Class II	Active
Corn, Cultivated, Zea mays	G202	FDA UDI	Class I	Unknown
NOVEOS Olive Tree, Olea europaea	T009	FDA UDI	Class II	Active
Autostat II Anti-Nuclear Antibody (ANA) Screen	FGA21	FDA UDI	Class II	Unknown
NOVEOS IgE Positive Control Pack	63150Z	FDA UDI	Class II	Active
Red Beet, Beta vulgaris	F136	FDA UDI	Class I	Unknown
NOVEOS Dog Dander, Canis familiaris	E005	FDA UDI	Class II	Active
Cockroach (Americana) Periplaneta americana	I100	FDA UDI	Class II	Unknown
NOVEOS Bahia Grass, Paspalum notatum	G017	FDA UDI	Class II	Active
Olive Tree Olea europaea	T009	FDA UDI	Class II	Unknown
NOVEOS Elm, Ulmus americana	T008	FDA UDI	Class II	Active
NOVEOS Bermuda Grass, Cynodon dactylon	G002	FDA UDI	Class II	Active
Autostat II Anti-ds-DNA	FGA01	FDA UDI	Class II	Unknown
NOVEOS House Dust Mite, Dermatophagoides farinae	D002	FDA UDI	Class II	Active
NOVEOS Mugwort, Artemisia douglasiana	W006	FDA UDI	Class II	Active
NOVEOS Cottonwood Tree, Populus deltoides	T014	FDA UDI	Class II	Active
Ragweed, Common Ambrosia elatior (artemisiifolia)	W001	FDA UDI	Class II	Unknown
[email protected]	E004	FDA UDI	Class II	Unknown
Autostat II Anti-GBM	FGA13	FDA UDI	Class II	Unknown
NOVEOS IgE Negative Control Pack	63155	FDA UDI	Class II	Active
NOVEOS House Dust - Greer	H001	FDA UDI	Class II	Active
Dockweed, Yellow Rumex crispus	W023	FDA UDI	Class II	Unknown
Pine, Ponderosa Pinus ponderosa	T042	FDA UDI	Class II	Unknown
Pepper, Green, Piper nigrum	F335	FDA UDI	Class I	Unknown
Autostat II IgM Rheumatoid Factor	FGA05	FDA UDI	Class II	Unknown
Cucumber, Cucumis sativus	F244	FDA UDI	Class I	Unknown
Goldenrod (European), Solidago virgaurea	W12	FDA UDI	Class I	Unknown
Rhizopus nigricans	M11	FDA UDI	Class I	Unknown
Willow, Black Salix nigra	T032	FDA UDI	Class II	Unknown
Vanilla, Vanilla planifolia	F234	FDA UDI	Class I	Unknown
NOVEOS Egg White, Gallus gallus	F001	FDA UDI	Class II	Active
Crayfish, Astacus astacus	F320	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.