Customerservices-us@hycorbiomedical.com 74383

GUDID 00816879021530

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Primary Device ID00816879021530
NIH Device Record Key616bb4d3-05b7-4805-960d-9e121f835b84
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustomerservices-us@hycorbiomedical.com
Version Model NumberM001
Catalog Number74383
Company DUNS010558476
Company NameHYCOR BIOMEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879021530 [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

On-Brand Devices [Customerservices-us@hycorbiomedical.com]

00816879021530A substance or reactant intended to be used together with a parent IVD to perform a specific fun
00816879021165A substance or reactant intended to be used together with a parent IVD to perform a specific fun
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