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Artisan Alpha Amylase
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AR171Model AR17111-2
Identity
- Trade Name
- Artisan Alpha Amylase EUDAMEDFDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Artisan Alpha Amylase EUDAMEDFDA UDI
- Model / Reference
- AR171 EUDAMEDFDA UDIAR17111-2 EUDAMED
- Description
- Artisan Alpha Amylase FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571100738 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A026501NK EUDAMED
- FDA Product Code
- LIJ FDA UDI
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4400 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Biological stain IVD
Artisan Alpha Amylase by Agilent Technologies Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Inc.
Sources (2)
- FDA UDI 02241cc5-14ea-4c95-a0a3-e322c30a41ee 36 fields · synced Jul 11, 2026
- EUDAMED 36416db1-41e8-4848-9a73-f5ded169634a 61 fields · synced Jul 11, 2026