IMMULITE Systems HCG CONTROL HCG (UDI 10385358)
Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Device Regulatory Overview
The IMMULITE Systems HCG CONTROL HCG (Model/Catalog Number: 10385358) is a medical device manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. This product is indexed under FDA Product Code / Category Classification DHA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 10385358
- Product Code / EMDN
- DHA
- Device Name
- HCG - IMMULITE - CTL - 2x2mL
- Database Sync Date
- 2026-08-09 09:32:41
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of IMMULITE Systems HCG CONTROL HCG?
The registered manufacturer of record for IMMULITE Systems HCG CONTROL HCG is SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
What is the Primary UDI-DI identifier for IMMULITE Systems HCG CONTROL HCG?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10385358.
What classification code is assigned to this device?
This device is registered under product classification code DHA.
Similar Classification Devices (DHA)
Other Devices by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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