FDA UDI In Commercial Distribution 🇺🇸 United States

Mohs Mouse/Rabbit PolyDetector HRP Green Detection System

DI: B502BSB03100 · Model: Kit, 15ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Mohs Mouse/Rabbit PolyDetector HRP Green Detection System
Primary DI
B502BSB03100
Version / Model
Kit, 15ml
Catalog Number
BSB 0310
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-31
Public Version
1
Public Version Date
2020-09-08
Public Version Status
New
Public Device Record Key
2c140450-fdad-448a-9e9d-8f9bd9deacea

Device Description

Detection system intended for the fast immunohistochemical detection of antibodies used for Mohs surgery on frozen or FFPE tissue sections.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NJT Immunohistochemistry Reagents And Kits

GMDN Terms

Code Name
57771 Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

Identifiers

Type ID
Primary B502BSB03100