Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit (UDI FHRWR100)
Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED
Device Regulatory Overview
The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit (Model/Catalog Number: FHRWR100) is a medical device manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED. This product is indexed under FDA Product Code / Category Classification JIT within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FHRWR100
- Product Code / EMDN
- JIT
- Device Name
- The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
- Database Sync Date
- 2026-08-09 09:08:16
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 Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit?
The registered manufacturer of record for Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit is AXIS-SHIELD DIAGNOSTICS LIMITED.
What is the Primary UDI-DI identifier for Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FHRWR100.
What classification code is assigned to this device?
This device is registered under product classification code JIT.
Similar Classification Devices (JIT)
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