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IMMULITE® Systems HCG Calibration Verification Material HCG
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems HCG Calibration Verification Material HCG FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, control FDA UDI
- Device Name
- HCG CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10387900 FDA UDI
- Description
- HCG CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LCGCVM FDA UDI
- Primary DI / UDI-DI
- 00630414973562 FDA UDI
- 510(k) Number
- K133128 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin 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 human chorionic gonadotropin IVD, control
IMMULITE® Systems HCG Calibration Verification Material HCG by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total human chorionic gonadotropin IVD, control.
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- AdexusDx hCG Control Set (unassayed) — NOWDIAGNOSTICS, INC. · Class I
- SAS hCG Serum Control Set — SA SCIENTIFIC, LTD
- SAS hCG Urine Control Set — SA SCIENTIFIC, LTD
- hCG Tri-Level Serum Controls — STANBIO LABORATORY, L.P. · Class I
- Sure-Vue hCG Serum Control Set — SA SCIENTIFIC, LTD
Cleared under the same submission
K133128 also covers:
- IMMULITE® GROWTH HORMONE CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems HCY Calibration Verification Material Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Systems INS Calibration Verification Material Insulin — 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 ffc18d9a-b7c5-4ec7-9af6-180fc69c2d8c 37 fields · synced May 30, 2026