IMMULITE/IMMULITE1000 Systems HBS HBsAg (UDI 10374038)
Manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Device Regulatory Overview
The IMMULITE/IMMULITE1000 Systems HBS HBsAg (Model/Catalog Number: 10374038) is a medical device manufactured by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. This product is indexed under FDA Product Code / Category Classification LOM within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 10374038
- Product Code / EMDN
- LOM
- Device Name
- HBS HBsAg Kit 100 Test
- Database Sync Date
- 2026-08-09 09:32:40
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/IMMULITE1000 Systems HBS HBsAg?
The registered manufacturer of record for IMMULITE/IMMULITE1000 Systems HBS HBsAg is SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
What is the Primary UDI-DI identifier for IMMULITE/IMMULITE1000 Systems HBS HBsAg?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10374038.
What classification code is assigned to this device?
This device is registered under product classification code LOM.
Similar Classification Devices (LOM)
Other Devices by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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