β2-Microglobulin assay (CLIA) (UDI D-7M19FH)
Manufactured by Xiamen Boson Biotech Co., Ltd.
Device Regulatory Overview
The β2-Microglobulin assay (CLIA) (Model/Catalog Number: 7M19V1-B-EU, 7M19U1-B-EU, 7M19P1-B-EU) is a medical device manufactured by Xiamen Boson Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102039002 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 7M19V1-B-EU, 7M19U1-B-EU, 7M19P1-B-EU
- Product Code / EMDN
- W0102039002
- Device Name
- β2-Microglobulin assay (CLIA)
- Database Sync Date
- 2026-08-09 16:51:15
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 β2-Microglobulin assay (CLIA)?
The registered manufacturer of record for β2-Microglobulin assay (CLIA) is Xiamen Boson Biotech Co., Ltd..
What is the Primary UDI-DI identifier for β2-Microglobulin assay (CLIA)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-7M19FH.
What classification code is assigned to this device?
This device is registered under product classification code W0102039002.
Similar Classification Devices (W0102039002)
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