gudid
Primary ID: DLHK7
DIMERTEST Latex assay (UDI DLHK7)
Manufactured by Biomedica ADI Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DIMERTEST Latex assay - Primary ID DLHK7
Device Regulatory Overview
The DIMERTEST Latex assay (Model/Catalog Number: DLHK7) is a medical device manufactured by Biomedica ADI Inc.. This product is indexed under FDA Product Code / Category Classification DAP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DLHK7
- Product Code / EMDN
- DAP
- Device Name
- Database Sync Date
- 2026-08-09 09:49:40
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 DIMERTEST Latex assay?
The registered manufacturer of record for DIMERTEST Latex assay is Biomedica ADI Inc..
What is the Primary UDI-DI identifier for DIMERTEST Latex assay?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DLHK7.
What classification code is assigned to this device?
This device is registered under product classification code DAP.
Similar Classification Devices (DAP)
Other Devices by Biomedica ADI Inc.
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