AccessGUDID - DEVICE: Mouse/Rabbit AmpliDetector Plus FITC with FluoroMounter (B502BSB0357500)

GUDID

Device Identifier (DI) Information

Brand Name: Mouse/Rabbit AmpliDetector Plus FITC with FluoroMounter
Version or Model: BSB-0357-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB-0357-50
Company Name: BIO SB, INC.

Primary DI Number: B502BSB0357500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.

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:	Yes
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?
57767	Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.	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: 50 Milliliter

Device Record Status

Public Device Record Key: c8e5e830-c0b8-4c71-a288-52881aec1ad7
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025