Detector Lex-IM

GUDID 10722355001491

A rapid latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis

Immunostics Company, Inc

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Primary Device ID10722355001491
NIH Device Record Keye3381e45-d013-47dc-a35c-4ff4d9cbfbd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector Lex-IM
Version Model NumberIMLX-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 Latextrue
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
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
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 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355001491 [Primary]
GS180722355001490 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2025-03-31
Device Publish Date2016-09-20

On-Brand Devices [Detector Lex-IM]

10722355001491A rapid latex agglutination slide test for the detection of heterophile antibodies associated wi
10722355001262A rapid latex agglutination slide test for the detection of heterophile antibodies associated wi
10722355001248A rapid latex agglutination slide test for the detection of heterophile antibodies associated wi

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