FDA.reportPublic FDA data

Hytec Automated EIA System for Total IgE and Specific IgE

Primary DI
00816879022322
Brand
Hytec Automated EIA System for Total IgE and Specific IgE
Company
HYCOR BIOMEDICAL LLC
Model
288-6002-350
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHBSystem, Test, Radioallergosorbent (Rast) Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHBSystem, Test, Radioallergosorbent (Rast) ImmunologicalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941278000HY-TEC AUTOMATED EIA SYSTEMHycor Biomedical, Inc.1995-03-13DHB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879022322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879022322008168790223228168790223220816879022322

GMDN Terms#

Term, Definition table
TermDefinition
Enzyme immunoassay (EIA) analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microtitre plates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00810053950135NOVEOS Almond, Amygdalus communisF0208634040Z2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkF078C63250-3Z2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusF0808632520Z2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutF352C63343Z2026-07-29
00810053950456NOVEOS Ara h 1, PeanutF422C63273Z2026-07-29
00810053950463NOVEOS Ara h 2, PeanutF423C63274-3Z2026-07-29
00810053950494NOVEOS Ara h 6, PeanutF447C63399Z2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumF01086322702026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusF08086325202026-07-29
00816879024333NOVEOS Ara h 1, PeanutF422C632732026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkF078C63250-32026-07-29
00816879024982NOVEOS Ara h 2, PeanutF423C63274-32026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutF352C633432026-07-29
00816879025354NOVEOS Soybean, Glycine maxF014632302026-07-29
00816879025378NOVEOS Ara h 6, PeanutF447C633992026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaF017632322026-07-29
00816879027969NOVEOS Almond, Amygdalus communisF02086340402026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950074NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950104NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950111NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950135NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950456NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCDHB2026-07-29
00816879027969NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCDHB2026-07-29
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCDHB2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCDHB2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCDHB2026-05-29