AccessGUDID - DEVICE: Total Haemolytic Complement (05051700010269)

GUDID

Device Identifier (DI) Information

Brand Name: Total Haemolytic Complement
Version or Model: RC001.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700010269
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62009	Total complement activity (CH50) IVD, kit, precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of total complement activity (CH50) in a clinical specimen using a precipitation/immunodiffusion method. It is useful in the investigation of recurrent bacterial infections, symptoms of inflammatory disease, and monitoring of chronic autoimmune conditions [e.g., systemic lupus erythematosus (SLE)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DAE	Complement C9, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992488	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: 01ddc073-d32a-4510-acc8-58e88ca5983a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016