AccessGUDID - DEVICE: 7-core HPV Cervical Cancer Cell Line Microarray Control Slides (B502BSB02940)

GUDID

Device Identifier (DI) Information

Brand Name: 7-core HPV Cervical Cancer Cell Line Microarray Control Slides
Version or Model: Control Slides, 5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0294
Company Name: BIO SB, INC.

Primary DI Number: B502BSB02940
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: 7-core HPV Cervical Cancer Cell Line Microarray cell line cores assembled in array fashion used as control

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43510	Biological stain control IVD	A prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0fe6f44c-f661-4ce4-b232-ccad74e3f9f5
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020