Identity
- Trade Name
- "Advance Dx Blood Collection Card EUDAMEDAdvance Dx 100 Blood Collection Card FDA UDI
- Generic Name
- Dried blood spot collection kit IVD FDA UDI
- Device Name
- Advance Dx 100 Blood Collection Card EUDAMEDAdvance Dx 100 Blood Collection Card, Non-sterile FDA UDI
- Model / Reference
- CMT01 EUDAMEDFDA UDI
- Description
- Advance Dx 100 Blood Collection Card, Non-sterile FDA UDI
Identifiers
- Catalog Number
- CMT01 FDA UDI
- Primary DI / UDI-DI
- 00860013988005 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600139880BUDI0003FZ EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W0501010199 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Dried blood spot collection kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Northern Ireland 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Inch FDA UDI
"Advance Dx Blood Collection Card by Advance Dx, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08600139880BUDI0003FZ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Advance Dx, Inc.
- EUDAMED SRN
- US-MF-000044758
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 72a5e49a-6327-4775-b9c3-0bbffc6c2bf7 61 fields · synced Jun 18, 2026
- FDA UDI 38587154-2be0-4a8b-9825-56b341b3e7e9 36 fields · synced May 30, 2026