Immpulse Coated Tube Phenobarbital Assay Reagents

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K865000 ↗

FDA Product Code

LET

Device Class

Class II

Regulation

21 CFR Part 862.3660

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sclavo, Inc. →

• What is the Immpulse Coated Tube Phenobarbital Assay Reagents used for?

  The Immpulse Coated Tube Phenobarbital Assay Reagents are used for the detection of Phenobarbital levels in a clinical setting, providing a quantitative measurement.

• How is the device supplied?

  The device is supplied with a product code of LET and is intended for use in conjunction with other equipment to produce a fluorescent signal.

• What is the storage and handling procedure for the device?

  The storage and handling of the device are not specified, but it is likely that the device should be stored in a cool, dry place and handled in accordance with standard laboratory procedures.

• Is the device single-use or reusable?

  The device is a coated tube assay reagent, suggesting it is single-use, but the exact usage instructions are not specified.