NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodon 8632350

GUDID 00816879023800

HYCOR BIOMEDICAL LLC

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Primary Device ID00816879023800
NIH Device Record Key3fe22065-5a93-4104-9cf2-cdafd35968d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodon
Version Model NumberF024
Catalog Number8632350
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 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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816879023800 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-28
Device Publish Date2026-01-20

On-Brand Devices [NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodon]

00816879023800F024
00810053950159F024

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