AccessGUDID - DEVICE: Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra® (05051700006347)

GUDID

Device Identifier (DI) Information

Brand Name: Freelite® Human Kappa Free Kit for use on the Roche Cobas Integra®
Version or Model: LK016.RI
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700006347
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2019
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?
53799	Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of kappa and/or lambda light chain immunoglobulins in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DFH	Kappa, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070900	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: 548adf16-4e43-4233-b507-cdefb49a5f9e
Public Version Date: April 17, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016