FDA UDI In Commercial Distribution 🇺🇸 United States

DIASTAT anti-B2 Glycoprotein-1 IgG

DI: 07340058410141 · Model: FBGP200 · Euro-Diagnostica AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DIASTAT anti-B2 Glycoprotein-1 IgG
Primary DI
07340058410141
Version / Model
FBGP200
Catalog Number
FBGP200
Company Name
Euro-Diagnostica AB
Labeler DUNS
559894501
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-08-12
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
79b81eff-ced5-4fec-b37d-e0e72c83a789

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

GMDN Terms

Code Name
54874 Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 07340058410141