Identity
- Trade Name
- ROTEM® FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. FDA UDI
- Model / Reference
- sigma ROTROL N FDA UDI
- Description
- The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses. Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected. FDA UDI
Identifiers
- Catalog Number
- 555201 FDA UDI
- Primary DI / UDI-DI
- 04260160470341 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, control
Rotem® by Tem Innovations GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, control.
- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Coagulation S.A.R.P (Specialty Assayed Reference Plasma) — Helena Laboratories, Corp. · Class II
- Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
- JAS Diagnostics — Drew Scientific , Ltd.
- CueSee® Coag — Eurotrol B.V. · Class II
- COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tem Innovations GmbH
Sources (1)
- FDA UDI 1f965628-3469-400f-ba55-feb1e9530245 35 fields · synced May 30, 2026