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TransFix/EDTA Vacuum Blood Collection Tube
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref TVT-03-1, TVT-03-2, TVT-03-50, TVT-09-1, TVT-09-2, TVT-09-50510(k) K162723
Identity
- Trade Name
- TransFix/EDTA Vacuum Blood Collection Tube FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, anticoagulant/cell preservative FDA UDI
- Device Name
- TransFix/EDTA Vacuum Blood Collection Tube EUDAMEDTransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis. FDA UDI
- Model / Reference
- TVT-03-1, TVT-03-2, TVT-03-50, TVT-09-1, TVT-09-2, TVT-09-50 EUDAMEDKC1030 FDA UDI
- Description
- TransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis. FDA UDI
Identifiers
- Catalog Number
- TVT-03-50 FDA UDI
- Primary DI / UDI-DI
- 05060531711603 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060531711603 EUDAMED
- FDA Product Code
- GIM FDA UDI
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
- GMDN Term
- Evacuated blood collection tube IVD, anticoagulant/cell preservative FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
TransFix/EDTA Vacuum Blood Collection Tube by Caltag Medsystems Ltd — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162723 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-05060531711603 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Caltag Medsystems Ltd
- EUDAMED SRN
- GB-MF-000021669
- FDA Applicant
- Caltag Medsystems, Ltd.
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED da4ccb27-87a1-49d7-b7d1-7d8b024505b5 85 fields · synced Jun 18, 2026
- FDA UDI 1d21a5f5-5a41-4037-be30-22492f89cea5 35 fields · synced May 30, 2026
- EUDAMED da4ccb27-87a1-49d7-b7d1-7d8b024505b5-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K162723 1 fields · synced May 18, 2026