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12 devices found
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Manufacturer: Trinity Biotech, Plc
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Lyme B. burgdorferi (IgG) MarStripe Test
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K163095
Active
Cleared 1 Feb 2017
Active
510(k)
510(k)
II
Uni-Gold Strep A Test Kit
Trinity Biotech, Plc
·
,
FDA registration: Ireland
Class I
FDA 510(k)
K982373
Active
Cleared 11 Feb 1999
Active
510(k)
510(k)
I
2 variants
Uni-Gold Strep A Test Kit
K011709
Herpes Group Igg
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K033059
Active
Cleared 26 Nov 2003
Active
510(k)
510(k)
II
Uni-Gold Cryptosporidium
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K121565
Active
Cleared 8 Feb 2013
Active
510(k)
510(k)
II
Rotavirus Eia
Trinity Biotech
·
,
United States
Class I
FDA 510(k)
K964424
Active
Cleared 8 Aug 1997
Active
510(k)
510(k)
I
Captiam Syphilis-G Assay
Trinity Biotech, Plc
·
,
FDA registration: Ireland
Class II
FDA 510(k)
K014233
Active
Cleared 24 Jan 2002
Active
510(k)
510(k)
II
Destiny Max Coagulation Analyzer
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K083896
Active
Cleared 2 Jul 2009
Active
510(k)
510(k)
II
Uni-Gold H. Pylori
Trinity Biotech, Plc
·
,
FDA registration: Ireland
Class I
FDA 510(k)
K991697
Active
Cleared 21 Dec 1999
Active
510(k)
510(k)
I
Lyme B. burgdorferi (IgM) MarStripe Test
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K172254
Active
Cleared 23 Oct 2017
Active
510(k)
510(k)
II
Unigold Giardia
Trinity Biotech
·
,
United States
Class II
FDA 510(k)
K120001
Active
Cleared 1 Mar 2013
Active
510(k)
510(k)
II
Captia Syphilis-G Elisa Test System
Trinity Biotech, Plc
·
,
FDA registration: Ireland
Class II
FDA 510(k)
K001525
Active
Cleared 29 Nov 2000
Active
510(k)
510(k)
II
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