AccessGUDID - DEVICE: Tinto CD117 RMab (B502BSB53170)

GUDID

Device Identifier (DI) Information

Brand Name: Tinto CD117 RMab
Version or Model: Predilute, 7 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 5317
Company Name: BIO SB, INC.

Primary DI Number: B502BSB53170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: CD117 is rabbit monoclonal antibody from supernatant diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative.

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?
57034	CD117 (c-kit) cell marker 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 CD117 (c-kit) cell marker in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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: 3118c3b4-4fcb-4c11-a5ac-0c9f7fec97ee
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 2020