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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 2 of 10

Device	Model / Reference	Registries	Class	Status
NOVEOS Bermuda Grass, Cynodon dactylon	G002	FDA UDI	Class II	Active
Blueberry, Vaccinium myrtillus	F288	FDA UDI	Class I	Unknown
White Poplar, Populus alba	T96	FDA UDI	Class I	Unknown
NOVEOS Meadow Fescue, Festuca elatior	G004	FDA UDI	Class II	Active
Sagebrush, Common Artemisia tridentata	W43	FDA UDI	Class I	Unknown
Parsley, Petrosilenum crispum	F86	FDA UDI	Class I	Unknown
Kochia/Firebush Kochia scoparia	W017	FDA UDI	Class II	Unknown
Cloves, Syzygium aromaticum	F268	FDA UDI	Class I	Unknown
Hytec Automated EIA System for Total IgE and Specific IgE	288-6002-350	FDA UDI	Class II	Unknown
NOVEOS Mulberry, Morus alba	T070	FDA UDI	Class II	Active
Millet, Panicum milliaceum	F55	FDA UDI	Class I	Unknown
Autostat II IgA Rheumatoid Factor	FGA06	FDA UDI	Class II	Unknown
NOVEOS Cocksfoot, Dactylis glomerata	G003	FDA UDI	Class II	Active
Scallop	F53	FDA UDI	Class I	Unknown
NOVEOS Capture Reagent Pack Kentucky Blue Grass, Poa pratensis	G008	FDA UDI	Class II	Active
NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium album	W010	FDA UDI	Class II	Active
IgE Reference Disc	74118	FDA UDI	Class II	Unknown
Asparagus, Asparagus officinalis	F261	FDA UDI	Class I	Unknown
NOVEOS House Dust Mite, Dermatophagoides pteronyssinus	D001	FDA UDI	Class II	Active
NOVEOS Pecan, Hickory, Carya illinoinensis	T022	FDA UDI	Class II	Active
Lobster, Homarus americanus	F80	FDA UDI	Class I	Unknown
Ragweed, False Franseria acanthicarpa	W004	FDA UDI	Class II	Unknown
Broccoli, Brassica oleracea var. botrytis	F260	FDA UDI	Class I	Unknown
NOVEOS Wall Pellitory, Parietaria officinalis	W019	FDA UDI	Class II	Active
Autostat II Anti-Tissue Transglutaminase IgG	FGA26	FDA UDI	Class II	Unknown
Crab	F023	FDA UDI	Class II	Unknown
Spinach, Spinacia oleracea	F214	FDA UDI	Class I	Unknown
Oregano, Origanum vulgare	F283	FDA UDI	Class I	Unknown
Autostat II Anti-B2-Glycoprotein I IgM	FGA23	FDA UDI	Class II	Unknown
Peach, Prunus persica	F95	FDA UDI	Class I	Unknown
Maple, Red, Acer rubrum	T27	FDA UDI	Class I	Unknown
Radish, Raphanus sativus	F119	FDA UDI	Class I	Unknown
NOVEOS Capture Reagent Pack Meadow Fescue, Festuca elatior	G004	FDA UDI	Class II	Active
Mesquite Prosopis glandulosa (juliflora)	T020	FDA UDI	Class II	Unknown
NOVEOS Dog Dander, Canis familiaris	E005	FDA UDI	Class II	Active
Oat	F007	FDA UDI	Class II	Unknown
Johnson Grass Sorghum halepense	G010	FDA UDI	Class II	Unknown
NOVEOS Mugwort, Artemisia douglasiana	W006	FDA UDI	Class II	Active
Hytec Probe Cleaning Solution	288197	FDA UDI	Class II	Unknown
Lamb, Ovis aries	F88	FDA UDI	Class I	Unknown
Pine, White Pinus strobus	T016	FDA UDI	Class II	Unknown
Cheese, American (Defatted)	F122	FDA UDI	Class I	Unknown
Birch, White Betula populifolia	T030	FDA UDI	Class II	Unknown
Goose Feathers	E70	FDA UDI	Class I	Unknown
Elm, Fall Blooming/Scrub Ulmus crassifolia	T045	FDA UDI	Class II	Unknown
NOVEOS Wash Buffer Concentrate Pack	63165Z	FDA UDI	Class II	Active
Hytec Specific/Total IgE EIA	74154	FDA UDI	Class II	Unknown
NOVEOS Cat Dander, Felis domesticus	E001	FDA UDI	Class II	Active
Autostat II Anti-Thyroid Peroxidase	FGA04	FDA UDI	Class II	Unknown
Stop Solution (Allergy)	308151	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.