Test, Urea (breath Or Blood)
Product Code: MSQ
Microbiology In Vitro And Other Medical Laser Products
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Laser Products. [1040.10]
Code of Federal Regulations: 866.3110
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| K223185 | BreathID® Smart System | Meridian Bioscience Israel Ltd. |
| K220494 | BreathID Hp Lab System, BreathID Smart System | Meridian Bioscience Israel Ltd. |
| K193610 | BreathID Smart System | Exalenz Bioscience Ltd. |
| K173777 | BreathID Hp Lab System | Exalenz Bioscience Ltd. |
| K173772 | BreathID Hp System | Exalenz Bioscience Ltd. |
| K162150 | BreathID Hp Lab System | Exalenz Bioscience Ltd. |
| K130524 | BREATHID HP SYSTEM | EXALENZ BIOSCIENCE LTD. |
| K093834 | CRIT-LINE ANEMIA MANAGEMENT SOFTWARE | HEMA METRICS, LLC |
| K092817 | POC-AS10 AUTO SAMPLER | OTSUKA PHARMACEUTICAL CO., LTD. |
| K041148 | POCONE INFRARED SPECTROPHOTOMETER | OTSUKA PHARMACEUTICAL CO., LTD. |
| K014225 | BREATHTEK - UBIT UBT FOR H. PYLORI | MERETEK DIAGNOSTICS, INC. |
| K011668 | VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI | ORIDION MEDICAL 1987 LTD. |
| K000316 | MERETEK UBT_LITE BREATH TEST FOR H. PYLORI | MERETEK |
| K990931 | EZ-HBT HELICOBACTER BLOOD TEST | METABOLIC SOLUTIONS, INC. |
| K973000 | ALIMENTERICS LARA (TM) BREATH TEST SYSTEM | ALIMENTERICS, INC. |
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