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Pacific Hemostasis APTT-XL
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 100403, J100403
by Fisher Diagnostics A division of Fisher Scientific Company, LLC
Identity
- Trade Name
- Thermo Scientific Pacific Hemostasis® FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Device Name
- Pacific Hemostasis APTT-XL EUDAMED
- Model / Reference
- 100403, J100403 EUDAMED100403 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845275000665 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845275000665 EUDAMED
- 510(k) Number
- K891337 FDA UDI
- FDA Product Code
- GFO FDA UDI
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
- GMDN Term
- Calcium chloride coagulation reagent IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pacific Hemostasis APTT-XL by Fisher Diagnostics A division of Fisher Scientific Company, LLC — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00845275000665 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- EUDAMED SRN
- US-MF-000029041
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED bfab4b48-df6a-48f0-b0d2-bb6625c3756c 61 fields · synced Oct 5, 2026
- FDA UDI ca86bb3c-55c7-47af-947a-bb1a73b81bba 35 fields · synced May 27, 2026
- EUDAMED bfab4b48-df6a-48f0-b0d2-bb6625c3756c-1 61 fields · synced Jun 10, 2026