DEVICE: Anti Human complement C5 (b1f) FITC (B1761102)

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Device Record History
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Device Identifier (DI) Information
Anti Human complement C5 (b1f) FITC
1
In Commercial Distribution
110202
KENT LABORATORIES INC
B1761102
HIBCC

1
093642254 *Terms of Use
Fluorescein conjugated polyclonal goat antiserum to Human complement C-5 (b1f)
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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?
61987 Complement component C5 IVD, kit, precipitation/immunodiffusion
A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C5 in a clinical specimen, using a precipitation/immunodiffusion method. It is useful in the investigation of conditions associated with C5 deficiency such as lupus erythematosus and recurrent Neiserria infections.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DAY Complement C5, Antigen, Antiserum, Control
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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 -20 and 6 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
2758241b-348a-43cb-a9a9-7c9c98d645b5
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)

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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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No Customer Contact currently defined
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