FDA UDI
In Commercial Distribution
🇺🇸 United States
DPP Zika IgM Micro Reader
DI: 00607158000113
·
Model: 70-1064-0
·
Chembio Diagnostic Systems Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DPP Zika IgM Micro Reader
- Primary DI
- 00607158000113
- Version / Model
- 70-1064-0
- Catalog Number
- 70-1064-0
- Company Name
- Chembio Diagnostic Systems Inc.
- Labeler DUNS
- 160348470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-19
- Public Version
- 1
- Public Version Date
- 2021-10-27
- Public Version Status
- New
- Public Device Record Key
- 2203a34b-2d14-4267-9094-4a7ebfa6584b
Device Description
The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader.
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | 862.2300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35827 | Photometer, reflectance | An instrument that measures the amount of light emitted by a light source, e.g., a light-emitting diode, as reflected from a sample in order to determine the concentration of an element. The device usually contains a photodiode for light detection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00607158000113 | GS1 |