Identity
- Trade Name
- A-LYTE IMT Cleaner FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- A-LYTE IMT Cleaner FDA UDI
- Model / Reference
- 11556782 FDA UDI
- Description
- A-LYTE IMT Cleaner FDA UDI
Identifiers
- Catalog Number
- 11556782 FDA UDI
- Primary DI / UDI-DI
- 00630414611617 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
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
Category: Wash/cleaning solution IVD, automated/semi-automated system
A-LYTE IMT Cleaner by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wash/cleaning solution IVD, automated/semi-automated system.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC. · Class I
- DAB Away — BIOCARE MEDICAL, LLC · Class I
- ACE — Alfa Wassermann, Inc.
- Capillary Adapter Cleaning Kit — Medica Corp. · Class II
- Rinse Solution II S4987 REF 944-155 600mL — Radiometer Medical ApS · Class II
- intelliPrep Solution — BIOCARE MEDICAL, LLC · Class I
- Grifols Wash Solution B — DIAGNOSTIC GRIFOLS SA · Class I
- CLC FAST DETERGENT 1 ALKALINE WASHING SOLUTION 100263 — Carolina Liquid Chemistries Corp. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI e0c9ba16-cc56-4208-b8b7-55bd0d41ecca 36 fields · synced Jun 6, 2026