FDA UDI
In Commercial Distribution
🇺🇸 United States
Elecsys beta-Amyloid (1-42) CSF II
DI: 07613336166321
·
Model: 08821941190
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Elecsys beta-Amyloid (1-42) CSF II
- Primary DI
- 07613336166321
- Version / Model
- 08821941190
- Catalog Number
- 08821941190
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-17
- Public Version
- 2
- Public Version Date
- 2023-08-08
- Public Version Status
- Update
- Public Device Record Key
- f97d8946-9c68-4f30-b2fe-072d687816b6
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| QSE | Alzheimer’s disease pathology assessment test | Immunology | 866.5840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65218 | Amyloid B component IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of amyloid B component, also known as amyloid beta or Aß, in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of Alzheimer's disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336166321 | GS1 |