AccessGUDID - DEVICE: Cytokeratin 18 Control Slides (B502BSB9138CS0)

GUDID

Device Identifier (DI) Information

Brand Name: Cytokeratin 18 Control Slides
Version or Model: BSB-9138-CS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-9138-CS
Company Name: BIO SB, INC.

Primary DI Number: B502BSB9138CS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: Cytokeratin 18 Control Slides

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?
38177	Cytokeratin IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	QUALITY CONTROL SLIDES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2584ed40-2646-439a-85da-8f2a34aba525
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025