AccessGUDID - DEVICE: Lambda light chains (08058056681263)

GUDID

Device Identifier (DI) Information

Brand Name: Lambda light chains
Version or Model: A26849
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A26849
Company Name: SENTINEL CH. SPA

Primary DI Number: 08058056681263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429572365 *Terms of Use

Device Description: The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 and Unicel DxC 600 Systems.

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?
53801	Kappa/lambda light chain immunoglobulin 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 kappa and/or lambda light chain immunoglobulins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEH	Lambda, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083601	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
Special Storage Condition, Specify: Store between 2 and 8 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 120 Milliliter

Device Record Status

Public Device Record Key: 526f85a0-e79a-415a-9e23-2fed082d55ee
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016