FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lumipulse G B-Amyloid Controls (Plasma)-N
DI: 04987270235485
·
Model: 235485
·
FUJIREBIO INC.
Product Codes
0
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Lumipulse G B-Amyloid Controls (Plasma)-N
- Primary DI
- 04987270235485
- Version / Model
- 235485
- Company Name
- FUJIREBIO INC.
- Labeler DUNS
- 710873907
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-06
- Public Version
- 3
- Public Version Date
- 2025-06-02
- Public Version Status
- Update
- Public Device Record Key
- 130df900-b2b6-421c-9b1d-922abcec70ec
- Distribution End Date
- 2025-01-06
Device Description
Lumipulse G B-Amyloid Controls (Plasma)-N
Device Characteristics
- Single Use
- No
- 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
- 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
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 |
| 65902 | Tau protein IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987270235485 | GS1 |
Customer Contacts
- Phone
- 610-240-3800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4 bottles per unit; 1.0mLs per bottle |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius