FDA UDI In Commercial Distribution 🇺🇸 United States

WIESLAB Capture MPO-ANCA

DI: 07340058410943 · Model: CapMPO US · Euro-Diagnostica AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
WIESLAB Capture MPO-ANCA
Primary DI
07340058410943
Version / Model
CapMPO US
Catalog Number
CapMPO US
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
0aac9ff9-695d-4df6-b83f-2681d30d7b6d

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
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

GMDN Terms

Code Name
55068 Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 07340058410943