FDA UDI
In Commercial Distribution
🇺🇸 United States
DIGIVAL
DI: 00811877010623
·
Model: EQ00600X
·
Alere Scarborough, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DIGIVAL
- Primary DI
- 00811877010623
- Version / Model
- EQ00600X
- Company Name
- Alere Scarborough, Inc.
- Labeler DUNS
- 154148498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-08
- Public Version
- 4
- Public Version Date
- 2023-09-12
- Public Version Status
- Update
- Public Device Record Key
- 5ba2b0d8-d8da-4d9b-82c1-473df590f79a
Device Description
DIGIVAL is a small bench top instrument to be used in conjunction with Abbott™ rapid tests.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42625 | Photometric/spectroscopic immunoassay analyser IVD | An electrically-powered instrument intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card), after vehicle exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in the clinical specimen. The instrument uses photometry and/or light spectroscopy to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by healthcare professionals for rapid in vitro diagnostic measurements [e.g., lateral flow immunochromatographic (ICT) test] 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 | 00811877010623 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162642 | 000 |