AccessGUDID - DEVICE: Anti Human C-3 Proactivator (Factor B) (B1761060)

GUDID

Device Identifier (DI) Information

Brand Name: Anti Human C-3 Proactivator (Factor B)
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 106002
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761060
Issuing Agency: HIBCC
Commercial Distribution End Date: September 21, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: goat antiserum to Human C-3 Proactivator

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62013	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.	Active	false

FDA Product Code

[?]

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2703f862-8a61-44c1-b0f5-32005bb6504f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016