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]
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| 3499 | Test, Urea (breath Or Blood) | Campylobacter Fetus Serological Reagents. |
| 3499 | Test, Urea (breath Or Blood) | Campylobacter Fetus Serological Reagents. |
| 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. |
| 07290016923223 | Test, Urea (Breath Or Blood) |
| 07290016923070 | Test, Urea (Breath Or Blood) |
| 07290016923056 | Test, Urea (Breath Or Blood) |
| 07290016923353 | Test, Urea (Breath Or Blood) |
| 07290016923346 | Test, Urea (Breath Or Blood) |
| 07290016923278 | Test, Urea (Breath Or Blood) |
| 07290016923162 | Test, Urea (Breath Or Blood) |
| 07290016923148 | Test, Urea (Breath Or Blood) |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2017-10-24 |
| BREATHTEK UBT KIT | OTSUKA PHARMACEUTICALS | 2017-06-02 |
| BREATHTEK UBT KIT | OTSUKA AMERICA PHARMACEUTICALS, INC. | 2016-09-29 |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2016-07-08 |
| BREATH TEK UBT KIT | OTSUKA AMERICA PHARMACEUTICALS INC. | 2015-04-14 |
| BREATH TEK UBT KIT | OTSUKA AMERICA PHARMACEUTICAL INC. | 2015-04-07 |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2015-04-01 |
| BREATHTEK SOLUTION | OTSUKA AMERICA | 2015-03-22 |
| BREATHTEK UBT KIT | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ | 2014-10-08 |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2014-03-21 |
| UBIT (13C-UREA) | OTSUKA AMERICA PHARMACEUTICAL INC. | 2013-07-03 |
| BREATHTEK UBT KIT | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ | 2012-08-30 |
| UBIT (13C-UREA) TABLET, 100MG MILLIGRAM(S) | OTSUKA AMERICA PHARMACEUTICAL INC. | 2012-08-03 |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2012-06-11 |
| BREATHTEK | OTSUKA PHARMACEUTICAL | 2012-05-30 |
| BREATHTEK (UBT) | 2011-05-31 | |
| BREATHTEK (UBT) | 2011-04-28 | |
| BREATHTEK (UBT) | OTSUKA AMERICA PHARMACEUTICAL COMPANY, INC. (OAPI) | 2009-05-28 |
| BREATHTEK UBT COLLECTION KIT | MERETEK DIAGNOSTICS, INC. | 2007-04-23 |
| BREATHTEK UBT COLLECTION KIT | MERETEK DIAGNOSTICS, INC. | 2007-01-17 |