DEVICE: Anti Human Properdin FITC (B1761082)

Device Identifier (DI) Information

Anti Human Properdin FITC
1
In Commercial Distribution
108202
KENT LABORATORIES INC
B1761082
HIBCC

1
093642254 *Terms of Use
Fluorescein conjugated polyclonal goat antiserum to Human Complement Properdin
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Complement reagent IVD A solution containing complement proteins intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. Typical uses may include HLA tissue typing by a complement-dependent cytotoxicity (CDC) method, or antigen-antibody based reactions by complement fixation test (CFT).
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FDA Product Code

[?]
Product Code Product Code Name
DHL Protein, Complement, 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

[?]
Size Type Text
No Device Sizes
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Device Record Status

497f95f3-e481-4776-8613-6812497b40d9
September 12, 2018
3
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
360-398-8641
donald@kentlabs.com
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