FDA UDI
In Commercial Distribution
🇺🇸 United States
N Antiserum to Human Albumin
DI: 00842768038020
·
Model: 10714509
·
Siemens Healthcare Diagnostics Products GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N Antiserum to Human Albumin
- Primary DI
- 00842768038020
- Version / Model
- 10714509
- Catalog Number
- OSAL25
- Company Name
- Siemens Healthcare Diagnostics Products GmbH
- Labeler DUNS
- 388240673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 9c7c15ce-96f1-472d-b86e-0d5ca8580635
Device Description
Quantitative determination of albumin in human serum, plasma, urine and CSF on BN Systems
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
- 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 |
|---|---|---|---|---|
| DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL | Immunology | 866.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53596 | Albumin IVD, kit, nephelometry/turbidimetry | 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 a nephelometry/turbidimetry method. It is typically used to aid in the diagnosis and monitoring of diseases affecting protein metabolism (e.g., liver disease, kidney disease, severe malnutrition, malabsorption, burns). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842768038020 | GS1 |
Customer Contacts
- Phone
- +1(800)664-3822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972929 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius