74 results
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34ms
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Sources: EU EUDAMED, US FDA
Saliva Collector
Device
EU IVDR
·
Eu Ivd Class A
·BEAVER Biomedical Engineering Co., Ltd.·On the market·3 countries
C.D.RICH
FDA UDI
Chengdu Rich Science Industry Co., Ltd.·16935238804582·It is used for collection, transportation, stor...
C.D.RICH
FDA UDI
Chengdu Rich Science Industry Co., Ltd.·16935238804551·It is used for collection, transportation, stor...
C.D.RICH
FDA UDI
Chengdu Rich Science Industry Co., Ltd.·16935238804568·It is used for collection, transportation, stor...
C.D.RICH
FDA UDI
Chengdu Rich Science Industry Co., Ltd.·16935238804575·It is used for collection, transportation, stor...
C.D.RICH
FDA UDI
Chengdu Rich Science Industry Co., Ltd.·16935238804544·It is used for collection, transportation, stor...
MolGen Saliva Collector
Device
EU IVDR
·
Eu Ivd Class A
·MolGen BV·No longer on the market
Saliva Sample Collector
Device
EU IVDR
·
Eu Ivd Class A
·Taizhou Sun Trine Biotechnology Co.,Ltd·On the market·6 countries
Saliva Sample Collector
Device
EU IVDR
·
Eu Ivd Class A
·Taizhou Sun Trine Biotechnology Co.,Ltd·On the market·6 countries
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
FDA 510(k)
FDA Class 1
·Dental
Saliva collectors. With medium. Blister package
Device
EU IVDR
·
Eu Ivd Class A
·Linear Chemicals S.L.U·On the market
Saliva collectors. Paper-poly pouch package
Device
EU IVDR
·
Eu Ivd Class A
·Linear Chemicals S.L.U·On the market
Saliva collectors. With medium. Paper-poly pouch package
Device
EU IVDR
·
Eu Ivd Class A
·Linear Chemicals S.L.U·On the market
Saliva collectors. With medium. Paper-poly pouch package
Device
EU IVDR
·
Eu Ivd Class A
·Linear Chemicals S.L.U·On the market
ISCREEN OFD SALIVA TEST
FDA Adverse Event
Malfunction
·ABON BIOPHARM (HANGZHOU) CO., LTD·Product code MVO·March 9, 2015
Saliva collector
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Taizhou Huangyan Fangye Technology Development Co.,Ltd.·1 device
Saliva collector
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·JIANGSU COMEON MEDICAL APPARATUS CO., LTD·28 devices
Saliva Collector
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BEAVER Biomedical Engineering Co., Ltd.·1 device
Saliva Collectors
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Biocomma Limited·4 devices
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test. Type of Packaging: 25 individually pouched test devices & collectors in a labeled kit box. The OrALert Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.
FDA Enforcement
Class II
·Terminated·Alere San Diego, Inc.·January 15, 2014