FDA UDI
In Commercial Distribution
🇺🇸 United States
Uric Acid Reagent
DI: 00812137012050
·
Model: 500mL
·
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Uric Acid Reagent
- Primary DI
- 00812137012050
- Version / Model
- 500mL
- Catalog Number
- 501-418
- Company Name
- CLINICAL DIAGNOSTIC SOLUTIONS, INC.
- Labeler DUNS
- 048144997
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b88337ce-f3a8-4957-ae2c-d692d35c2b8a
Device Description
For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | Clinical Chemistry | 862.1775 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53586 | Uric acid IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812137012050 | GS1 |
Customer Contacts
- Phone
- 8004533328
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius