Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
- Device Name
- The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The IDG APTT-EA reagent is an in vitro diagnostic assay intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. FDA UDI
Identifiers
- Catalog Number
- HC201 FDA UDI
- Primary DI / UDI-DI
- 00850053916199 FDA UDI
- 510(k) Number
- K022021 FDA UDI
- FDA Product Code
- GFO FDA UDI
- GMDN Term
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Category: Activated partial thromboplastin time (APTT) IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Activated partial thromboplastin time (APTT) IVD, reagent.
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Dade Actin FSL Activated PTT Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Pathromtin® SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- QuikCoag APTT-EA — Biomedica Diagnostics Inc · Class II
- Dade Actin FS Activated PTT Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade® Actin® Activated Cephaloplastin Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Pathromtin SL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Dade® Actin® FS Activated PTT Reagent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI f66d24df-6d63-492b-8407-b8e38d00a895 35 fields · synced May 30, 2026