Identity
- Trade Name
- STA® - HBPM/LMWH Control FDA UDI
- Generic Name
- Heparin anti-Xa IVD, control FDA UDI
- Model / Reference
- 00682 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450006827 FDA UDI
- 510(k) Number
- K943519 FDA UDI
- FDA Product Code
- KFF FDA UDI
- GMDN Term
- Heparin anti-Xa IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7525 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Heparin anti-Xa IVD, control
STA® - HBPM/LMWH Control by Diagnostica Stago, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heparin anti-Xa IVD, control.
- INNOVANCE Heparin LMW Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- INNOVANCE Heparin LMW Control 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- BIOPHEN UFH Control C1 — HYPHEN BIOMED · Class II
- BIOPHEN UFH Control Plasma — HYPHEN BIOMED · Class II
- BIOPHEN LMWH CONTROL LOW CI — HYPHEN BIOMED · Class II
- INNOVANCE Heparin UF Control 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- INNOVANCE Heparin LMW Control 2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- BIOPHEN LMWH Control C4 — HYPHEN BIOMED · Class II
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
- Diagnostica Stago, Inc.
Sources (1)
- FDA UDI b5baadd6-f8cf-4d5a-bfa3-5d945ad5545c 34 fields · synced May 30, 2026