gudid
Primary ID: 1430-003
TRUE 20 Sample Pack (UDI 1430-003)
Manufactured by STANBIO LABORATORY, L.P.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TRUE 20 Sample Pack - Primary ID 1430-003
Device Regulatory Overview
The TRUE 20 Sample Pack (Model/Catalog Number: 1430-003) is a medical device manufactured by STANBIO LABORATORY, L.P.. This product is indexed under FDA Product Code / Category Classification JHI within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1430-003
- Product Code / EMDN
- JHI
- Device Name
- A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
- Database Sync Date
- 2026-08-09 09:17:29
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 TRUE 20 Sample Pack?
The registered manufacturer of record for TRUE 20 Sample Pack is STANBIO LABORATORY, L.P..
What is the Primary UDI-DI identifier for TRUE 20 Sample Pack?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1430-003.
What classification code is assigned to this device?
This device is registered under product classification code JHI.
Similar Classification Devices (JHI)
Other Devices by STANBIO LABORATORY, L.P.
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