Thermo Scientific Pacific Hemostasis (UDI 100604)
Manufactured by Fisher Diagnostics
Device Regulatory Overview
The Thermo Scientific Pacific Hemostasis (Model/Catalog Number: 100604) is a medical device manufactured by Fisher Diagnostics. This product is indexed under FDA Product Code / Category Classification GGN within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays....
Pacific Hemostasis Thromboplastin-D, 4 ml. Used in performing one-stage prothrombin time test and factor assays....
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fish...
Technical Specifications
- Model Number
- 100604
- Product Code / EMDN
- GGN
- Device Name
- Database Sync Date
- 2026-08-09 09:21:10
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 Thermo Scientific Pacific Hemostasis?
The registered manufacturer of record for Thermo Scientific Pacific Hemostasis is Fisher Diagnostics.
What is the Primary UDI-DI identifier for Thermo Scientific Pacific Hemostasis?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 100604.
What classification code is assigned to this device?
This device is registered under product classification code GGN.
Similar Classification Devices (GGN)
Other Devices by Fisher Diagnostics
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint