FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DG Reader
DI: 08437014205176
·
Model: 213779
·
DIAGNOSTIC GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DG Reader
- Primary DI
- 08437014205176
- Version / Model
- 213779
- Catalog Number
- 213779
- Company Name
- DIAGNOSTIC GRIFOLS SA
- Labeler DUNS
- 463625602
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 6
- Public Version Date
- 2025-04-14
- Public Version Status
- Update
- Public Device Record Key
- f88f72df-bb48-4d71-a16b-0ad3772d8c39
- Distribution End Date
- 2025-04-11
Device Description
The DG Reader is a device designed to read, interpret, and generate reports of the results of processed DG Gel 8 cards. The instruments also identifies DG Gel 8 cards by Reading their barcodes. As a stand-alone instrument or interfaced to the customer's Laboratory Information System (LIS), the DG Reader automates data management requirements using DG Gel 8 cards and digital image processing.
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 |
|---|---|---|---|---|
| PBC | Manual Blood Grouping And Antibody Test Systems | Hematology | 864.9175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64179 | Agglutination assay digital imaging reader/analyser IVD | An electrically-powered laboratory instrument designed to be used to capture digital images of a clinical specimen from a dedicated specimen slide/cartridge/card and provide image analysis of an agglutination or haemagglutination assay. It is a benchtop instrument that includes a tray, slot or drawer, where the specimen is placed for optical image acquisition, and dedicated software for analysis, visualization and storage of the acquired images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08437014205176 | GS1 |
Customer Contacts
- Phone
- (800)452-6877
- [email protected]