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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 9 of 10

Device	Model / Reference	Registries	Class	Status
Hytec Autommune Kit (ena)	K954890	FDA 510(k)	Class II	Active
Hycor Specific Ige Enzyme Immunoassay	K945748	FDA 510(k)	Class II	Active
Ventrex Coated Tube High Sensit. Tsh Radioimmunoas	K920856	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Rf Auto-Antibody	K962729	FDA 510(k)	Class II	Active
Hytec Autoimmune Kits (ss-B)	K954891	FDA 510(k)	Class II	Active
White Ash - Fraxinus Americana (t15) Allergen Disc	K921574	FDA 510(k)	Class II	Active
Hytec Autoimmune Kits (rnp)	K954897	FDA 510(k)	Class II	Active
Hycor Allergen Disc	K965094	FDA 510(k)	Class II	Active
Hycor Accupinch Methamphetamine Test	K904115	FDA 510(k)	Class II	Active
Specific Ige Eia-Turbo Assay	K925425	FDA 510(k)	Class II	Active
Hycor Accupinch Morphine Test	K900173	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Scl-70 Auto-Antibody	K962720	FDA 510(k)	Class II	Active
Drugs Of Abuse Urine Calibrators	K892332	FDA 510(k)	Class II	Active
Autostat Ii Anti-Cardiolipin Iga Elisa	K030741	FDA 510(k)	Class II	Active
Baseline Calibration Verification Controls	K923284	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Rnp Auto-Antibody	K962727	FDA 510(k)	Class II	Active
Hytec Autoimmune Kits (scl-70)	K954894	FDA 510(k)	Class II	Active
Hycor Sentry Drugs Of Abuse Urine Calibrators	K894934	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Ena Auto-Antibody	K962728	FDA 510(k)	Class II	Active
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus	K182479	FDA 510(k)	Class II	Active
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg	K252775	FDA 510(k)	Class II	Active
Hy-Tec Total Ige Enzyme Immunoassay	K940183	FDA 510(k)	Class II	Active
Autostat Ii Anti-Tisue Transglutaminase Iga Elisa	K033744	FDA 510(k)	Class II	Active
Autostat Ii Anti-B-2 Glycoprotein-I Igm Elisa	K022944	FDA 510(k)	Class II	Active
Hy-Tec Specific And Total Ige Eia System	K081217	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Ss-A Auto-Antibody	K962719	FDA 510(k)	Class II	Active
Pyloragen Helicbacter Pylori Test Kit - Modified	K923445	FDA 510(k)	Class I	Active
Hytec Automimmune Kit (rf)	K954892	FDA 510(k)	Class II	Active
Hy-Tec/Manual Autoimmune Kit For Thyroglobulin (tg)	K962341	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Sm Auto-Antibody	K962722	FDA 510(k)	Class II	Active
Hy-Tec/Manual Autoimmune Kit For Thyroid Microsomal (tpo)	K962451	FDA 510(k)	Class II	Active
Hycor Accupinch Thc Test	K901334	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Ds-Dna Auto-Antibody	K962730	FDA 510(k)	Class II	Active
Hy-Tec/Manual Autoimmune Kit For Histone	K962450	FDA 510(k)	Class II	Active
Autostat Ii Anti-Tissue Transglutaminase Igg Elisa	K043433	FDA 510(k)	Class II	Active
Specific Ige Eia-Ultra Assay	K941057	FDA 510(k)	Class II	Active
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria	K220162	FDA 510(k)	Class II	Active
Specific Ige Ultra-Eia	K945884	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Ss-B Auto-Antibody	K962578	FDA 510(k)	Class II	Active
Hycor Pyloragen Helicobacter Pylori Test	K912255	FDA 510(k)	Class I	Active
Autostat Ii Anti-B-2 Glycoprotein I Igg Elisa	K022945	FDA 510(k)	Class II	Active
Hycor Hy.tec/Manual Jo-1 Auto-Antibody	K962731	FDA 510(k)	Class II	Active
Kova Liqua-Trol	K942853	FDA 510(k)	Class I	Active
Hytec Autoimmune Kits (sm)	K954896	FDA 510(k)	Class II	Active
Autostat Ii Anti-B-2 Glycoprotein I Iga Elisa	K030397	FDA 510(k)	Class II	Active
Hycor Sentry(tm) Drugs Of Abuse Urine Calibrators	K893815	FDA 510(k)	Class II	Active
Hytec Automimmune Kit (ds-Dna)	K954893	FDA 510(k)	Class II	Active
Hytec Autoimmune Kit (jo-1)	K954895	FDA 510(k)	Class II	Active
Hy-Tec/Manual Autoimmune Kit For Mitochondria	K962452	FDA 510(k)	Class II	Active
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae	K191510	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

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.