Detector Mono

GUDID 20722355001252

A qualitative immunoassay for the detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma

IMMUNOSTICS COMPANY, INC

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Primary Device ID20722355001252
NIH Device Record Key2097c11a-3375-4dbf-b50b-07d15f77fd75
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector Mono
Version Model NumberIDM-25
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355001255 [Primary]
GS120722355001252 [Package]
Contains: 10722355001255
Package: Case of 10 [10 Units]
In Commercial Distribution
GS180722355001254 [Unit of Use]

FDA Product Code

KTNSYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-09-22

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