Identity
- Trade Name
- DG Reader FDA UDI
- Generic Name
- Agglutination assay digital imaging reader/analyser IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 213779 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 213779 FDA UDI
- Primary DI / UDI-DI
- 08437014205176 FDA UDI
- FDA Product Code
- PBC FDA UDI
- GMDN Term
- Agglutination assay digital imaging reader/analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DG Reader by Diagnostic Grifols Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Grifols Sa
Sources (1)
- FDA UDI f88f72df-bb48-4d71-a16b-0ad3772d8c39 36 fields · synced Jun 8, 2026