FDA UDI In Commercial Distribution 🇺🇸 United States

PSAP MMab

DI: B502BSB59060 · Model: Concentrate, 0.1 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
PSAP MMab
Primary DI
B502BSB59060
Version / Model
Concentrate, 0.1 ml
Catalog Number
BSB 5906
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
2025-02-28
Public Version Status
Update
Public Device Record Key
2066d3d9-6dc4-4106-ae6f-3e1a249d58af

Device Description

PSAP is a mouse 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
56754 Prostatic acid phosphatase (PAP) IVD, antibody

Identifiers

Type ID
Primary B502BSB59060