FDA UDI
In Commercial Distribution
🇺🇸 United States
ProciseDx Analyzer
DI: 08100322943909
·
Model: 4390
·
Chembio Diagnostic Systems Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProciseDx Analyzer
- Primary DI
- 08100322943909
- Version / Model
- 4390
- Company Name
- Chembio Diagnostic Systems Inc.
- Labeler DUNS
- 160348470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-05
- Public Version
- 2
- Public Version Date
- 2025-07-11
- Public Version Status
- Update
- Public Device Record Key
- 654cf0ba-1d0c-42d8-9fdb-cd1a2e59729c
Device Description
The ProciseDx Analyzer is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The ProciseDx Analyzer should be used in accordance with user documentation and facility specific regulations. For in vitro diagnostic use only.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | Immunology | 866.5270 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56705 | Fluorescent immunoassay analyser IVD, laboratory | 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 in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), 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 | 08100322943909 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 130 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity