Identity
- Trade Name
- APTT-SA (Soluble Activator) Reagent Kit FDA UDI
- Generic Name
- Activated partial thromboplastin time (APTT) IVD, reagent FDA UDI
- Model / Reference
- 5389 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52553890 FDA UDI
- 510(k) Number
- K915418 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Activated partial thromboplastin time (APTT) IVD, reagent
APTT-SA (Soluble Activator) Reagent Kit by Helena Laboratories, Corp. — 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
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- QuikCoag APTT-EA — Biomedica Diagnostics Inc · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · 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
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI e7b75140-55c9-460a-819e-e33bdf63c35c 34 fields · synced Jun 9, 2026