AccessGUDID - DEVICE: TintoFast Prame (RBT-PRAME) (B502BSB3774150)

GUDID

Device Identifier (DI) Information

Brand Name: TintoFast Prame (RBT-PRAME)
Version or Model: BSB-3774-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-3774-15
Company Name: BIO SB, INC.

Primary DI Number: B502BSB3774150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: TintoFast Prame is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5

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?
65250	Preferentially expressed antigen in melanoma (PRAME) 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 preferentially expressed antigen in melanoma (PRAME) protein 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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 15 Milliliter

Device Record Status

Public Device Record Key: d696d9d0-ecc4-450f-9c79-1d6f3d80d7e7
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025