Identity
- Trade Name
- DG Spin FDA UDI
- Generic Name
- Gel column agglutination centrifuge IVD FDA UDI
- Device Name
- DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards. FDA UDI
- Model / Reference
- 210363 FDA UDI
- Description
- DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards. FDA UDI
Identifiers
- Catalog Number
- 210363 FDA UDI
- Primary DI / UDI-DI
- 08437014205152 FDA UDI
- FDA Product Code
- PBC FDA UDI
- GMDN Term
- Gel column agglutination centrifuge 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
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
Category: Gel column agglutination centrifuge IVD
DG Spin by Diagnostic Grifols Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gel column agglutination centrifuge IVD.
- MTS — MICRO TYPING SYSTEMS, INC · Class II
- MTS — MICRO TYPING SYSTEMS, INC · Class I
- LT Medical Centrifuge for Blood Grouping Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- ORTHO — Ortho-Clinical Diagnostics · Class II
- LT Medical Centrifuge for Blood Grouping Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Grifols Sa
Sources (1)
- FDA UDI 1c363f4e-e112-4b87-b283-8c90a4498bb8 36 fields · synced Jun 1, 2026