AccessGUDID - DEVICE: IFE Free Lambda Light Chain Antiserum (M52594130)

GUDID

Device Identifier (DI) Information

Brand Name: IFE Free Lambda Light Chain Antiserum
Version or Model: 9413
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M52594130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079396131 *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:	Yes
Prescription Use (Rx):	Yes
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?
57325	Kappa/lambda light chain immunoglobulin 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 kappa and/or lambda light chain immunoglobulins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CZN	IGA, FITC, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891683	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9d8ac2f-db8c-4e80-881c-c8886e376e37
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 07, 2016