Hytec Automated EIA System for Total IgE and Specific IgE

GUDID 00816879022322

HYCOR BIOMEDICAL LLC

Enzyme immunoassay (EIA) analyser IVD, automated Enzyme immunoassay (EIA) analyser IVD, automated Enzyme immunoassay (EIA) analyser IVD, automated Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD Enzyme immunoassay (EIA) analyser IVD
Primary Device ID00816879022322
NIH Device Record Key0f1d1b18-c96d-495d-87c9-a1c74b8eeac9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHytec Automated EIA System for Total IgE and Specific IgE
Version Model Number288-6002-350
Company DUNS010558476
Company NameHYCOR BIOMEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com
Phone800-382-2527
EmailCustomerservices-us@hycorbiomedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879022322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DHBSystem, Test, Radioallergosorbent (Rast) Immunological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

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