AccessGUDID - DEVICE: Peroxidase conjugated Antiserum to Human IgG (B1761018)

GUDID

Device Identifier (DI) Information

Brand Name: Peroxidase conjugated Antiserum to Human IgG
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 101872
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761018
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 093642254 *Terms of Use

Device Description: No description.

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?
41353	Total immunoglobulin G (IgG total) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DAA	Igg, Peroxidase, 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: 971288e5-577d-491e-94db-b28020aa890b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016