Identity
- Trade Name
- ADVIA® Chemistry Multi-Drug Urine Controls 1,2 FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
- Device Name
- Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL FDA UDI
- Model / Reference
- 10282987 FDA UDI
- Description
- Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL FDA UDI
Identifiers
- Catalog Number
- 6520064 FDA UDI
- Primary DI / UDI-DI
- 00630414550916 FDA UDI
- 510(k) Number
- K040758 FDA UDI
- FDA Product Code
- CIC FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ADVIA® Chemistry Multi-Drug Urine Controls 1, 2 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K040758 also covers:
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI a355553c-aeb4-48dd-a568-2fb859034610 38 fields · synced Jun 6, 2026