FDA UDI
In Commercial Distribution
🇺🇸 United States
Exdia TRF Plus
DI: 08800026300083
·
Model: PD-FC20
·
Precision Biosensor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Exdia TRF Plus
- Primary DI
- 08800026300083
- Version / Model
- PD-FC20
- Catalog Number
- PD-FC20
- Company Name
- Precision Biosensor Inc.
- Labeler DUNS
- 688454363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-16
- Public Version
- 2
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- df668127-ebd9-4d7c-be0a-85b2a5510a5b
Device Description
A reader for the Exdia cartridges (immunofluorescence assay).
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| JZT | Fluorometer | Immunology | 866.4520 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61039 | Fluorescent immunoassay/spectrophotometry analyser IVD, point-of-care | A portable, electrically-powered point-of-care instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative and/or qualitative in vitro determination of cells and/or markers, chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen and uses a spectrophotometric method to measure the absorbance of chemical and/or biological markers. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800026300083 | GS1 |