FDA UDI
In Commercial Distribution
🇺🇸 United States
Clinistix Kidney Health Test System
DI: 00630414631707
·
Model: 11643376
·
Siemens Healthcare Diagnostics Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- Clinistix Kidney Health Test System
- Primary DI
- 00630414631707
- Version / Model
- 11643376
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2024-05-03
- Public Version
- 1
- Public Version Date
- 2024-05-13
- Public Version Status
- New
- Public Device Record Key
- 41504e8d-5d10-4b5e-a052-74dae4519e22
Device Description
Test Strips for the Determination of Albumin and Creatinine in Urine
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JFY | Enzymatic Method, Creatinine | Clinical Chemistry | 862.1225 | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54523 | Urine protein IVD, kit, rapid colorimetric, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for protein within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00630414317434 | GS1 | ||||
| Primary | 00630414631707 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991315 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store upright