A rapid chromatographic immunoassay for the qualitative detection of Hydromorphone in urine at a cut-off concentration of 250ng/ml. (UDI D-DHM-ACO111T3)
Manufactured by Acro Biotech Inc.
Device Regulatory Overview
The A rapid chromatographic immunoassay for the qualitative detection of Hydromorphone in urine at a cut-off concentration of 250ng/ml. (Model/Catalog Number: DHM-ACO111) is a medical device manufactured by Acro Biotech Inc.. This product is indexed under FDA Product Code / Category Classification W0102160599 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DHM-ACO111
- Product Code / EMDN
- W0102160599
- Device Name
- Hydromorphone (HMO) Rapid Test
- Database Sync Date
- 2026-08-09 16:29:28
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 A rapid chromatographic immunoassay for the qualitative detection of Hydromorphone in urine at a cut-off concentration of 250ng/ml.?
The registered manufacturer of record for A rapid chromatographic immunoassay for the qualitative detection of Hydromorphone in urine at a cut-off concentration of 250ng/ml. is Acro Biotech Inc..
What is the Primary UDI-DI identifier for A rapid chromatographic immunoassay for the qualitative detection of Hydromorphone in urine at a cut-off concentration of 250ng/ml.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-DHM-ACO111T3.
What classification code is assigned to this device?
This device is registered under product classification code W0102160599.
Similar Classification Devices (W0102160599)
Other Devices by Acro Biotech Inc.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint