Identity
- Trade Name
- Dimension® HCG Calibrator FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, calibrator FDA UDI
- Device Name
- Human Chorionic Gonadotropin Calibrator, 2x5x2mL FDA UDI
- Model / Reference
- 10445019 FDA UDI
- Description
- Human Chorionic Gonadotropin Calibrator, 2x5x2mL FDA UDI
Identifiers
- Catalog Number
- RC430 FDA UDI
- Primary DI / UDI-DI
- 00842768013737 FDA UDI
- 510(k) Number
- K970396 FDA UDI
- FDA Product Code
- JIW FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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, calibrator
Dimension® HCG Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, calibrator.
- Calibrator Kit – hCG — QUALIGEN INC. · Class II
- AIA-PACK HCG CALIBRATOR SET — Tosoh Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI e55f9a9a-2247-4a93-bc31-0ca17d88150c 37 fields · synced May 30, 2026