Identity
- Trade Name
- Hanks Solution FDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- For washing of lymphocytes in the microlymphocytotoxicity test, free of Ca and Mg, not for infusion FDA UDI
- Model / Reference
- 824035 FDA UDI
- Description
- For washing of lymphocytes in the microlymphocytotoxicity test, free of Ca and Mg, not for infusion FDA UDI
Identifiers
- Catalog Number
- 824035 FDA UDI
- Primary DI / UDI-DI
- 07611969953080 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Cell culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Hanks Solution by Bio-Rad Medical Diagnostics GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI a776e897-9c0e-4cfc-aed7-c582bf8af683 37 fields · synced Jun 1, 2026