FDA UDI In Commercial Distribution 🇺🇸 United States

PolyDetector Alk Brown Ready-To-Use

DI: B502BSB00720 · Model: 15 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
PolyDetector Alk Brown Ready-To-Use
Primary DI
B502BSB00720
Version / Model
15 ml
Catalog Number
BSB 0072
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
2
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
525e2590-bedf-4d53-9c95-069b15ca2989

Device Description

PolyDetector Alk Brown Ready-to-Use Substrate-Chromogen is a solution suitable for use in immunohistochemical, immunocytochemical and in situ hybridization procedures using Alkaline Phosphatase Detection Systems

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
58239 Chromogenic/colorimetric substrate reagent IVD

Identifiers

Type ID
Primary B502BSB00720