FDA UDI
In Commercial Distribution
🇺🇸 United States
UASure II Blood Uric Acid Test Strips 25s
DI: 00886338000048
·
Model: S5640997
·
APEX BIOTECHNOLOGY CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- UASure II Blood Uric Acid Test Strips 25s
- Primary DI
- 00886338000048
- Version / Model
- S5640997
- Catalog Number
- S5640997
- Company Name
- APEX BIOTECHNOLOGY CORP.
- Labeler DUNS
- 657608092
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-12-27
- Public Version
- 1
- Public Version Date
- 2022-01-04
- Public Version Status
- New
- Public Device Record Key
- b264b0e7-c24c-47a0-b62c-132048848c8b
Device Description
25s foil packet
Device Characteristics
- Single Use
- Yes
- 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
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00886338000062 | GS1 | ||||
| Primary | 00886338000048 | GS1 |