FDA UDI In Commercial Distribution 🇺🇸 United States

Mouse/Rabbit PolyDetector AEC HRP Red Detection System

DI: B502BSB02080 · Model: 200 ml each · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Mouse/Rabbit PolyDetector AEC HRP Red Detection System
Primary DI
B502BSB02080
Version / Model
200 ml each
Catalog Number
BSB 0208
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-30
Public Version
1
Public Version Date
2020-10-08
Public Version Status
New
Public Device Record Key
c5175a21-8247-4169-a41d-69b81e60346b

Device Description

Mouse/Rabbit PolyDetector AEC HRP Red is a one-step polymeric detection system that allows for the demonstration of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
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 B502BSB02080