FDA UDI In Commercial Distribution 🇺🇸 United States

Uric Acid ver.2

DI: 04015630925124 · Model: 5171857190 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Uric Acid ver.2
Primary DI
04015630925124
Version / Model
5171857190
Catalog Number
5171857190
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-18
Public Version
2
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
2d192a38-a4cb-4728-a016-95c66e8e8144

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KNK Acid, uric, uricase (colorimetric)

GMDN Terms

Code Name
53583 Uric acid IVD, kit, spectrophotometry

Identifiers

Type ID
Primary 04015630925124