DEVICE: C1 Esterase Inhibitor RID plate kit (B1761355)
Device Identifier (DI) Information
C1 Esterase Inhibitor RID plate kit
1
In Commercial Distribution
135511
KENT LABORATORIES INC
1
In Commercial Distribution
135511
KENT LABORATORIES INC
Radial immunodiffusion plate package for Human C1 Esterase Inhibitor with standards
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? |
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62030 | Complement component C1 inhibitor IVD, kit, precipitation/immunodiffusion |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1 inhibitor in a clinical specimen, using a precipitation/immunodiffusion method. It is used to assess C1 inhibitor activity which is associated with hereditary angioneurotic oedma.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JZQ | Plates And Equipment, Radial Immunodiffusion |
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: between 4 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5dffb00e-f304-4e27-bd82-9c624ea9d784
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 |
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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
[?]
3603988641
donald@kentlabs.com
donald@kentlabs.com