FDA UDI In Commercial Distribution 🇺🇸 United States

Tinto Prostein/P501S, RMab

DI: L502BSB3163 · Model: Predilute, 7 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Tinto Prostein/P501S, RMab
Primary DI
L502BSB3163
Version / Model
Predilute, 7 ml
Catalog Number
BSB 3163
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-01
Public Version
1
Public Version Date
2020-06-09
Public Version Status
New
Public Device Record Key
5a9510a9-2947-4e0e-9cee-47283f5a2bbf

Device Description

Tinto Prostein/P501S 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
57505 p501s IVD, antibody

Identifiers

Type ID
Primary L502BSB3163