Coagulation S.A.R.P (Specialty Assayed Reference Plasma) (UDI 5185)
Manufactured by HELENA LABORATORIES CORPORATION
Device Regulatory Overview
The Coagulation S.A.R.P (Specialty Assayed Reference Plasma) (Model/Catalog Number: 5185) is a medical device manufactured by HELENA LABORATORIES CORPORATION. This product is indexed under FDA Product Code / Category Classification GGN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5185
- Product Code / EMDN
- GGN
- Device Name
- Database Sync Date
- 2026-08-09 09:36:16
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 Coagulation S.A.R.P (Specialty Assayed Reference Plasma)?
The registered manufacturer of record for Coagulation S.A.R.P (Specialty Assayed Reference Plasma) is HELENA LABORATORIES CORPORATION.
What is the Primary UDI-DI identifier for Coagulation S.A.R.P (Specialty Assayed Reference Plasma)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5185.
What classification code is assigned to this device?
This device is registered under product classification code GGN.
Similar Classification Devices (GGN)
Other Devices by HELENA LABORATORIES CORPORATION
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