FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro-Albumin ELISA
DI: 00840239038814
·
Model: EIA-3881
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Micro-Albumin ELISA
- Primary DI
- 00840239038814
- Version / Model
- EIA-3881
- Catalog Number
- EIA-3881
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-20
- Public Version
- 4
- Public Version Date
- 2023-07-25
- Public Version Status
- Update
- Public Device Record Key
- a54e7aa5-f185-4968-aaaf-81c30ea47957
Device Description
Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 53476 | Microalbumin IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microalbumin in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239038814 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Calibrators | ||
| Device Size Text, specify | Enzyme Conjugate | ||
| Total Volume | 0.5 | Milliliter | |
| Device Size Text, specify | Stop Solution | ||
| Device Size Text, specify | Wash Buffer | ||
| Device Size Text, specify | Controls +/- | ||
| Device Size Text, specify | TMB Substrate | ||
| Total Volume | 20 | Milliliter | |
| Total Volume | 15 | Milliliter | |
| Device Size Text, specify | Sample Diluent |