MSQ · Test, Urea (Breath Or Blood)
Microbiology · 21 CFR 866.3110 · Class 1
Overview
| Product Code | MSQ |
|---|---|
| Device Name | Test, Urea (Breath Or Blood) |
| Regulation | 21 CFR 866.3110 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases. Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221896 | BreathID Hp System | Meridian Bioscience Israel , Ltd. | Dec 19, 2022 | SESE |
| K223185 | BreathID® Smart System | Meridian Bioscience Israel , Ltd. | Nov 10, 2022 | SESE |
| K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel , Ltd. | Jun 23, 2022 | SESE |
| K193610 | BreathID Smart System | Exalenz Bioscience , Ltd. | Feb 6, 2020 | SESE |
| K173777 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | Mar 8, 2018 | SESE |
| K173772 | BreathID Hp System | Exalenz Bioscience , Ltd. | Mar 8, 2018 | SESE |
| K162150 | BreathID Hp Lab System | Exalenz Bioscience , Ltd. | Oct 31, 2016 | SESE |
| K130524 | BREATHID HP SYSTEM | Exalenz Bioscience , Ltd. | May 22, 2013 | SESE |
| K093834 | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE | Hema Metrics, LLC | Sep 29, 2010 | SESE |
| K092817 | POC-AS10 AUTO SAMPLER | Otsuka Pharmaceutical Co., Ltd. | Mar 9, 2010 | SESE |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | Otsuka Pharmaceutical Co., Ltd. | Jul 15, 2004 | SESE |
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | Meretek Diagnostics, Inc. | Jan 17, 2002 | SESE |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | Oridion Medical 1987 , Ltd. | Jul 9, 2001 | SESE |
| K000316 | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI | Meretek | Feb 24, 2000 | SESE |
| K990931 | EZ-HBT HELICOBACTER BLOOD TEST | Metabolic Solutions, Inc. | Sep 24, 1999 | SESE |
| K973000 | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM | Alimenterics, Inc. | Feb 26, 1998 | SESE |
| K972352 | THE MERETEK UBT BREATH TEST FOR H.PYLORI | Meretek Diagnostics, Inc. | Oct 29, 1997 | SESE |
Top Applicants
- Exalenz Bioscience , Ltd. — 5 clearances
- Meridian Bioscience Israel , Ltd. — 3 clearances
- Otsuka Pharmaceutical Co., Ltd. — 2 clearances
- Meretek Diagnostics, Inc. — 2 clearances
- Oridion Medical 1987 , Ltd. — 1 clearance
