DEVICE: Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System (B110ME60060)
Device Identifier (DI) Information
Measles (Rubeola) Virus Antigen Substrate, 6 wells, For IFA Test System
ME-6006
Not in Commercial Distribution
ME-6006
Bion Enterprises, Ltd.
ME-6006
Not in Commercial Distribution
ME-6006
Bion Enterprises, Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
49294 | Measles virus immunoglobulin G (IgG) antibody IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Measles virus in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GRE | Antiserum, Fluorescent, Rubeola |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2f7392ff-9498-4642-8811-c8c619f7a7c6
March 04, 2020
3
August 02, 2016
March 04, 2020
3
August 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
847-544-5044
bion@mblintl.com
bion@mblintl.com