FDA UDI In Commercial Distribution 🇺🇸 United States

URIC ACID (UA)

DI: 05055273206746 · Model: UA3870 · RANDOX LABORATORIES LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
URIC ACID (UA)
Primary DI
05055273206746
Version / Model
UA3870
Company Name
RANDOX LABORATORIES LIMITED
Labeler DUNS
227530649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-10-05
Public Version
2
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
b6367d33-8871-420b-b659-9d4ce59ab0b2

Device Description

For the quantitative in vitro determination of Uric Acid in serum, plasma and urine.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
53583 Uric acid IVD, kit, spectrophotometry

Identifiers

Type ID
Primary 05055273206746

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius