Identity
- Trade Name
- IMMULITE® 2000 Systems PRL Prolactin FDA UDI
- Generic Name
- Prolactin IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Prolactin - IMMULITE - RGT - 600 Tests FDA UDI
- Model / Reference
- 10381199 FDA UDI
- Description
- Prolactin - IMMULITE - RGT - 600 Tests FDA UDI
Identifiers
- Catalog Number
- L2KPR6 FDA UDI
- Primary DI / UDI-DI
- 00630414961941 FDA UDI
- 510(k) Number
- K925846 FDA UDI
- FDA Product Code
- CFT FDA UDI
- GMDN Term
- Prolactin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1625 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: Prolactin IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems PRL Prolactin by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Prolactin IVD, kit, chemiluminescent immunoassay.
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- VITROS — Ortho-Clinical Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Elecsys Prolactin II — Roche Diagnostics Corp. · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- iFlash-Prolactin — Shenzhen YHLO Biotech Co., Ltd. · Class I
Cleared under the same submission
K925846 also covers:
- IMMULITE 2000 Prolactin Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE 2000 Prolactin Kit Domestic 600T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems PRL Prolactin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems PRL Prolactin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 40163df0-140e-4f4f-87b7-95c59c513b3d 37 fields · synced May 30, 2026