AccessGUDID - DEVICE: Antiserum to Human C1 Esterase Inhibitor (B1761350)

GUDID

Device Identifier (DI) Information

Brand Name: Antiserum to Human C1 Esterase Inhibitor
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 135002
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: Goat antiserum to Human C1 Esterase Inhibitor

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?
62030	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DBA	Complement C1 Inhibitor (Inactivator), 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: 8bb57a4b-df24-4a86-b76e-7159113ade9c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016