Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems PAP FDA UDI
- Generic Name
- Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- PAP - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10380953 FDA UDI
- Description
- PAP - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKPA1 FDA UDI
- Primary DI / UDI-DI
- 00630414964355 FDA UDI
- 510(k) Number
- K931701 FDA UDI
- FDA Product Code
- JFH FDA UDI
- GMDN Term
- Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1020 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: Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems PAP by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay.
Cleared under the same submission
K931701 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 Products Ltd
Sources (1)
- FDA UDI 2e710f09-1ec1-4393-aae4-3c35b8ca510d 37 fields · synced Jun 8, 2026