Identity
- Trade Name
- DG Gel 8 Neutral FDA UDI
- Generic Name
- Column agglutination IVD FDA UDI
- Device Name
- The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210393 FDA UDI
- Description
- The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use as a control microtube. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210393 FDA UDI
- Primary DI / UDI-DI
- 08437014205008 FDA UDI
- FDA Product Code
- KSZ FDA UDI
- GMDN Term
- Column agglutination IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Column agglutination IVD
DG Gel 8 Neutral by Diagnostic Grifols Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 85ef1d7f-e9d5-4d40-884c-1339a24a7632 36 fields · synced Jun 6, 2026