FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio30+ System Physio Accel
DI: 05056336800192
·
Model: 80-6000-50
·
BIOCHROM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio30+ System Physio Accel
- Primary DI
- 05056336800192
- Version / Model
- 80-6000-50
- Company Name
- BIOCHROM LIMITED
- Labeler DUNS
- 235280646
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-14
- Public Version
- 1
- Public Version Date
- 2023-07-24
- Public Version Status
- New
- Public Device Record Key
- 115dc653-b2a8-448a-8db5-33b8b3069205
Device Description
Ion exchange chromatography analyzer with lithium accelerated column, LED monitor, computer, autosampler and Openlab software
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57801 | Amino acid analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of individual amino acids in a protein sample obtained from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056336800192 | GS1 |