AccessGUDID - DEVICE: Human Fibrinogen BINDARID™ Radial Immunodiffusion Kit (05051700010726)

GUDID

Device Identifier (DI) Information

Brand Name: Human Fibrinogen BINDARID™ Radial Immunodiffusion Kit
Version or Model: RN056.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700010726
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 347045614 *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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Fibrinogen (Factor I) assay IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of fibrinogen (Factor I) in a clinical specimen.

FDA Product Code

[?]

Product Code	Product Code Name
KQJ	System, Fibrinogen Determination

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922416	000

Device Exempt from Premarket Submission: No 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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02cb565a-b098-4571-a1a8-5d13e7f2336c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016