FDA UDI
Not in Commercial Distribution
🇺🇸 United States
B.R.A.H.M.S Basiskit LIA
DI: 04260157633711
·
Model: 371.0
·
B.R.A.H.M.S GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B.R.A.H.M.S Basiskit LIA
- Primary DI
- 04260157633711
- Version / Model
- 371.0
- Company Name
- B.R.A.H.M.S GmbH
- Labeler DUNS
- 343844205
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- dc8af346-7ff0-4239-8c6c-7022ee5a99e9
- Distribution End Date
- 2017-01-01
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 |
|---|---|---|---|---|
| NTM | Antigen, Inflammatory Response Marker, Sepsis | Microbiology | 866.3210 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58793 | Chemiluminescent immunoassay signal generation kit IVD | A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260157633711 | GS1 |