FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro-Albumin
DI: 00198168683255
·
Model: ORG 5MA
·
ORGENTEC Diagnostika GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Micro-Albumin
- Primary DI
- 00198168683255
- Version / Model
- ORG 5MA
- Catalog Number
- ORG 5MA
- Company Name
- ORGENTEC Diagnostika GmbH
- Labeler DUNS
- 328133103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-14
- Public Version
- 1
- Public Version Date
- 2023-12-22
- Public Version Status
- New
- Public Device Record Key
- 2657c810-19e6-478d-8359-095cf8117826
Device Description
Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is intended for professional in vitro diagnostic use only. The rate of albumin excertion in urine is an important control and prevention parameter for the evaluation of kidney function. If the glomerular filtration process is highly active, albumin excretion may be elevated without any kidney damage. Physical stress may also cause microalbuminuria.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | 862.1645 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53598 | Albumin IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198168683255 | GS1 |