AccessGUDID - DEVICE: Rabbit FluoroDetector FITC with FluoroMounter (B502BSB03150)

GUDID

Device Identifier (DI) Information

Brand Name: Rabbit FluoroDetector FITC with FluoroMounter
Version or Model: 15 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0315
Company Name: BIO SB, INC.

Primary DI Number: B502BSB03150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: The Rabbit FluoroDetector FITC with FluoroMounter kit is intended for the 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?	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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 047f1787-438e-4053-be09-5164afe5b1ad
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020