GEM Test APTT Cartridges (UDI 06260034000)
Manufactured by INSTRUMENTATION LABORATORY COMPANY
Device Regulatory Overview
The GEM Test APTT Cartridges (Model/Catalog Number: 06260034000) is a medical device manufactured by INSTRUMENTATION LABORATORY COMPANY. This product is indexed under FDA Product Code / Category Classification JPA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 06260034000
- Product Code / EMDN
- JPA
- Device Name
- GEM Test APTT Cartridges
- Database Sync Date
- 2026-08-09 09:10:50
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of GEM Test APTT Cartridges?
The registered manufacturer of record for GEM Test APTT Cartridges is INSTRUMENTATION LABORATORY COMPANY.
What is the Primary UDI-DI identifier for GEM Test APTT Cartridges?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06260034000.
What classification code is assigned to this device?
This device is registered under product classification code JPA.
Similar Classification Devices (JPA)
Other Devices by INSTRUMENTATION LABORATORY COMPANY
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint