AccessGUDID - DEVICE: N FLC CONTROL SL2 (00630414237503)

GUDID

Device Identifier (DI) Information

Brand Name: N FLC CONTROL SL2
Version or Model: 10873663
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPJF05
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414237503
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN 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):	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?
41431	Kappa/lambda light chain immunoglobulin IVD, control	A material which is used to verify the performance of an assay intended to be 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
DFH	KAPPA, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171742	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: bf4980a0-3f07-4d9b-9aa7-b4419b8eb1c8
Public Version Date: March 18, 2024
Public Version Number: 5
DI Record Publish Date: October 08, 2018