NOVEOS Gray Alder, Alnus incana 8633070Z

GUDID 00816879029338

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Primary Device ID00816879029338
NIH Device Record Key938f5681-bc2d-4d9c-b4e4-b743357854b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVEOS Gray Alder, Alnus incana
Version Model NumberT002
Catalog Number8633070Z
Company DUNS010558476
Company NameHYCOR BIOMEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879029338 [Primary]

FDA Product Code

PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

On-Brand Devices [NOVEOS Gray Alder, Alnus incana]

00816879024661T002
00816879029338T002

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