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
B1761355
HIBCC

1
093642254 *Terms of Use
Radial immunodiffusion plate package for Human C1 Esterase Inhibitor with standards
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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
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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FDA Product Code

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Product Code Product Code Name
JZQ Plates And Equipment, Radial Immunodiffusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 4 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

5dffb00e-f304-4e27-bd82-9c624ea9d784
March 29, 2018
2
September 24, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
3603988641
donald@kentlabs.com
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