FDA UDI
In Commercial Distribution
🇺🇸 United States
DxI 9000 Access Immunoassay Analyzer
DI: 15099590732103
·
Model: C11137
·
Beckman Coulter, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DxI 9000 Access Immunoassay Analyzer
- Primary DI
- 15099590732103
- Version / Model
- C11137
- Catalog Number
- C11137
- Company Name
- Beckman Coulter, Inc.
- Labeler DUNS
- 008254708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-31
- Public Version
- 1
- Public Version Date
- 2023-01-09
- Public Version Status
- New
- Public Device Record Key
- e7f009ea-a090-4321-8adc-5556da5ecc33
Device Description
The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
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
- 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 |
|---|---|---|---|---|
| 56701 | Chemiluminescent immunoassay 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 chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15099590732103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221225 | 000 |