Identity
- Trade Name
- Stratus® CS Acute Care™ DDMR DilPak FDA UDI
- Generic Name
- D-dimer IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The Stratus® CS Acute Care(TM) D-dimer Dilution Pak (DDMR DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) DDMR TestPak for the measurement of samples with elevated levels of D-dimer. FDA UDI
- Model / Reference
- 10445077 FDA UDI
- Description
- The Stratus® CS Acute Care(TM) D-dimer Dilution Pak (DDMR DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) DDMR TestPak for the measurement of samples with elevated levels of D-dimer. FDA UDI
Identifiers
- Catalog Number
- CDDMR-D FDA UDI
- Primary DI / UDI-DI
- 00842768004582 FDA UDI
- 510(k) Number
- K063356 FDA UDI
- FDA Product Code
- DAP FDA UDI
- GMDN Term
- D-dimer IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7320 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
No
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: D-dimer IVD, kit, fluorescent immunoassay
Stratus® CS Acute Care™ DDMR DilPak by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as D-dimer IVD, kit, fluorescent immunoassay.
- Fluoro-CheckTM D-Dimer — Nano-Ditech Corporation · Class II
- Triage — Quidel Cardiovascular Inc. · Class II
- Triage — Quidel Cardiovascular Inc. · Class II
- Acute Care™ D-DIMER CalPak — Siemens Healthcare Diagnostics · Class II
- Stratus® CS Acute Care™ DDMR TestPak — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K063356 also covers:
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 00d657eb-d24d-4937-bed2-b6c1a25c5867 37 fields · synced May 30, 2026