DEVICE: Anti Human Complement C-3 Proactivator FITC (B1761062)
Device Identifier (DI) Information
Anti Human Complement C-3 Proactivator FITC
1
In Commercial Distribution
106202
KENT LABORATORIES INC
1
In Commercial Distribution
106202
KENT LABORATORIES INC
Fluorescein conjugated polyclonal goat antiserum to Human complement C-3 Proactivator (Factor B)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
62013 | Complement factor B IVD, kit precipitation/immunodiffusion |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of complement factor B of the alternative pathway in a clinical specimen, using a precipitation/immunodiffusion method. Elevated levels of complement factor B are associated with infection and trauma.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JZH | Factor B, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 6 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a1eb63c7-ec84-4621-82a2-d93588fb22f4
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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
[?]
360-398-8641
donald@kentlabs.com
donald@kentlabs.com