DEVICE: Detector Monocol Lex (10722355001651)

Device Identifier (DI) Information

Detector Monocol Lex
MCLX-25
In Commercial Distribution

IMMUNOSTICS COMPANY, INC
10722355001651
GS1

25
119214195 *Terms of Use
A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.
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FDA Product Code

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Product Code Product Code Name
KTN SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5c5a01d6-2f04-4ed6-a9af-5f897eb7197c
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 80722355001650 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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