AccessGUDID - DEVICE: Anti Human Complement C-3 Proactivator FITC (B1761062)

GUDID

Device Identifier (DI) Information

Brand Name: Anti Human Complement C-3 Proactivator FITC
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106202
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761062
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: Fluorescein conjugated polyclonal goat antiserum to Human complement C-3 Proactivator (Factor B)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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 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.

FDA Product Code

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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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 6 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1eb63c7-ec84-4621-82a2-d93588fb22f4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016