NOVEOS Redtop, Bentgrass, Agrostis stolonifera 8634620

GUDID 00816879027976

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Primary Device ID00816879027976
NIH Device Record Key8b1d8482-b66b-4310-9871-51331c6ce3cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVEOS Redtop, Bentgrass, Agrostis stolonifera
Version Model NumberG009
Catalog Number8634620
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879027976 [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 Date2025-04-04
Device Publish Date2025-03-27

Devices Manufactured by HYCOR BIOMEDICAL LLC

00816879027976 - NOVEOS Redtop, Bentgrass, Agrostis stolonifera2025-04-04
00816879027976 - NOVEOS Redtop, Bentgrass, Agrostis stolonifera2025-04-04
00816879027556 - NOVEOS Aspergillus fumigatus2025-02-19
00816879024043 - NOVEOS Elm, Ulmus americana2025-01-10
00816879024012 - NOVEOS Maple Box Elder, Acer negundo2024-10-29
00816879025194 - NOVEOS Wall Pellitory, Parietaria officinalis2024-10-29
00816879028300 - NOVEOS Sheep Sorrel, Rumex acetosella2024-10-29
00816879024166 - NOVEOS Russian Thistle, Salsola kali2024-10-07
00816879024906 - NOVEOS English Plantain, Plantago lanceolata2024-10-07

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