Identity
- Trade Name
- ASTUTE140 Electronic Quality Control (EQC) Device FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Model / Reference
- 400016 FDA UDI
Identifiers
- Catalog Number
- 400016 FDA UDI
- Primary DI / UDI-DI
- B0744000160 FDA UDI
- FDA Product Code
- PIG FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluorescent immunoassay analyser IVD, laboratory
ASTUTE140 Electronic Quality Control (EQC) Device by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, laboratory.
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- Phadia 100 — Phadia GmbH · Class II
- AutoDELFIA Plate processor — Wallac, Inc. · Class I
- Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN — Carolina Liquid Chemistries Corp. · Class I
- AutoDELFIA Sample Processor — Wallac, Inc. · Class I
- ALFIS-3 — Boditech Med, Inc.
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 |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (1)
- FDA UDI 81f2d37d-0568-45bd-806e-9c234d3c74b9 33 fields · synced Jun 8, 2026