FDA UDI In Commercial Distribution 🇺🇸 United States

CHORUS ECHINOCOCCUS IgG

DI: 08033891320010 · Model: 81284 · DIESSE DIAGNOSTICA SENESE SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
CHORUS ECHINOCOCCUS IgG
Primary DI
08033891320010
Version / Model
81284
Catalog Number
81284
Company Name
DIESSE DIAGNOSTICA SENESE SPA
Labeler DUNS
435036669
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-22
Public Version
1
Public Version Date
2024-01-30
Public Version Status
New
Public Device Record Key
9790d6e8-7b2c-439a-9330-6f2e30a7d864

Device Characteristics

Single Use
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GPF Antigen, Agglutinating, Echinococcus Spp.

GMDN Terms

Code Name
52219 Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 08033891320010