FDA UDI In Commercial Distribution 🇺🇸 United States

CD15 RMab

DI: B502BSB28550 · Model: Concentrate, 0.1 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CD15 RMab
Primary DI
B502BSB28550
Version / Model
Concentrate, 0.1 ml
Catalog Number
BSB 2855
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-16
Public Version
2
Public Version Date
2025-03-05
Public Version Status
Update
Public Device Record Key
c38426fd-fced-4f41-9ad0-56e6e8631473

Device Description

CD15 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5

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
No
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
56948 CD15 cell marker IVD, antibody

Identifiers

Type ID
Primary B502BSB28550