FDA product code MTL: Monitor,Test,Hiv-1
MTL is the FDA product code for monitor,test,hiv-1. It is a Class III device, reviewed by the Hematology panel. Devices under MTL reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for MTL devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor,Test,Hiv-1 |
| Device class | Class III |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for MTL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-20.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0400 — Home sleep test (hst) with type iv portable monitor, unattended; minimum of 3 channels
Frequently asked questions
What is FDA product code MTL?
MTL is the FDA product code for monitor,test,hiv-1. It is a Class III device, reviewed by the Hematology panel.
What device class is MTL?
Class III. Typical premarket route: Contact FDA.
Have MTL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MTL
- Run a recall and safety report across every MTL manufacturer
- Watch product code MTL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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