FDA UDI
In Commercial Distribution
🇺🇸 United States
IMMAGE
DI: 15099590224073
·
Model: 447760
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMMAGE
- Primary DI
- 15099590224073
- Version / Model
- 447760
- Catalog Number
- 447760
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 4
- Public Version Date
- 2023-08-28
- Public Version Status
- Update
- Public Device Record Key
- 5ac4d655-5384-4077-9313-d13b5bab5e28
Device Description
IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JZH | Factor B, Antigen, Antiserum, Control | Immunology | 866.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62016 | Complement factor B IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative measurement of complement factor B of the alternative pathway in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590224073 | GS1 |