AccessGUDID - DEVICE: Anti Human Alpha 2 Macroglobulin FITC (B1761242)

GUDID

Device Identifier (DI) Information

Brand Name: Anti Human Alpha 2 Macroglobulin FITC
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 124202
Company Name: KENT LABORATORIES INC

Primary DI Number: B1761242
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 Alpha 2 Macroglobulin

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?
53926	Alpha-2-macroglobulin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alpha-2-macroglobulin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DDY	Alpha-2-Macroglobulin, Fitc, 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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 964d9a6a-4e2e-4cb1-93b0-2c03b5f659dd
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016