FDA UDI In Commercial Distribution 🇺🇸 United States

HPV16, MMab

DI: B502BSB29480 · Model: Concentrate, 1 ml · BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HPV16, MMab
Primary DI
B502BSB29480
Version / Model
Concentrate, 1 ml
Catalog Number
BSB 2948
Company Name
BIO SB, INC.
Labeler DUNS
102855447
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-31
Public Version
1
Public Version Date
2020-09-08
Public Version Status
New
Public Device Record Key
206c88bb-2cbf-4f91-9646-8330d45b9e27

Device Description

Anti-human papillomavirus 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
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
MVU Reagents, Specific, Analyte

GMDN Terms

Code Name
64541 Human papillomavirus (HPV) antigen IVD, antibody

Identifiers

Type ID
Primary B502BSB29480