Identity
- Trade Name
- IMMULITE® 3RD GEN. PSA CVM FDA UDI
- Generic Name
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
- Device Name
- 3rd Generation PSA CVM - IMMULITE – CONS FDA UDI
- Model / Reference
- 10713725 FDA UDI
- Description
- 3rd Generation PSA CVM - IMMULITE – CONS FDA UDI
Identifiers
- Catalog Number
- L3PSCVM FDA UDI
- Primary DI / UDI-DI
- 00630414601939 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total prostate specific antigen (tPSA) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- 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
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
Category: Total prostate specific antigen (tPSA) IVD, control
Immulite® 3rd Gen. Psa Cvm by Siemens Healthcare Diagnostics Products Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI e3541290-2bd1-4a48-856e-273a45a52cc9 36 fields · synced May 31, 2026