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FDA-Registered Company Profile for TRINITY BIOTECH, PLC
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| FDA-Supplied Establishment Information: |
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| Establishment Registration Number: |
9681576 |
| Company Name: |
TRINITY BIOTECH, PLC |
| Address: |
IDA BUSINESS PARK BRAY |
| Address 2: |
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| City: |
CO. WICKLOW |
| State |
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| Zip / Postal Code: |
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| County: |
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| Country: |
EI |
| Establishment Operation Code(s): |
MM - Manufacturer
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| Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
9025161 |
| Company Name: |
TRINITY BIOTECH, PLC
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| Address: |
IDA BUSINESS PARK BRAY |
| Address 2: |
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| City: |
CO. WICKLOW |
| State: |
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| Zip / Postal Code: |
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| Country: |
EI |
| Owner/Operator Phone: |
353-127-69800
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| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MS. FIONA CAMPBELL |
| Company Name: |
TRINITY BIOTECH, PLC |
| Address: |
IDA BUSINESS PARK BRAY |
| Address 2: |
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| City: |
CO. WICKLOW |
| State: |
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| Zip / Postal Code: |
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| Country: |
EI |
| Official Corespondent Phone Number: |
35-31-2769800
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| FDA-Supplied US Agent Information: |
| US Agent Contact Name / Title: |
MRS BONNIE DEJOY |
| Company Name: |
TRINITY BIOTECH USA |
| Address: |
2823 GIRTS RD. |
| Address 2: |
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| City: |
JAMESTOWN |
| State: |
NY |
| Zip Code: |
14702 |
| Country: |
EI |
| US Agent Phone Number: |
716-483-3851 |
| US Agent Email Address: |
bonnie.dejoy@trinityusa.com
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| Other Establishment Information: |
| Establishment Phone: |
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| Fax: |
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| General Email: |
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| Web Site: |
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| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
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| Differentiation: |
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FDA-Registered Products Offered by TRINITY BIOTECH, PLC
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Common Device Name |
Proprietary Device Name |
| 1 |
ABNORMAL PLASMA CONTROL |
VERIFY LA CONTROL |
| 2 |
AGGREGOMETER PLATELET |
COLLAGEN REAGENT, ADP REAGENT, EPINEPHRINE RGT, RISTOCETIN REAGENT, PLATELET AGG |
| 3 |
ANGIOTENSIN CONVERTING ENZYME TEST SYSTEM |
ACE REAGENT |
| 4 |
ANTIGENS AGAINST ADENOVIRUS 1-33 |
BARTEB ANTI ADENO AB |
| 5 |
ANTITHROMBIN III TEST |
ANTITHROMBIN III |
| 6 |
AUTOMATED PARTIAL THROMBOPLASTIN TEST AND CONTROLS |
MDA PLATELIN L, PLATELIN L, AUTOMATED APTT, CALCIUM CHLORIDE |
| 7 |
BARTELS C. DIFFICILE TOXIN A ANTIGEN EIA WITH CONTROLS |
BARTELS C. DIFFICILE TOXIN A ANTIGEN EIA WITH CONTROLS |
| 8 |
BARTELS CHLAMYDIA DIRECT SPECIMEN FA KIT |
BARTELS CHLAMYDIA DIRECT SPECIMEN FA KIT |
| 9 |
BARTELS CHLAMYDIA INDIRECT IMMUNOPEROXIDASE KIT |
BARTELS CHLAMYDIA INDIRECT IMMUNOPEROXIDASE KIT |
| 10 |
BARTELS CHLAMYDIA ISOLATION MEDIUM |
BARTELS CHLAMYDIA ISOLATION MEDIUM |
| 11 |
BARTELS CMV MONOCLONAL DFA KIT |
BARTELS CMV MONOCLONAL DFA KIT |
| 12 |
BARTELS LEGIONELLA URINARY ANTIGEN EIA |
BARTELS LEGIONELLA URINARY ANTIGEN EIA |
| 13 |
BARTELS RSV EIA KIT |
BARTELS RSV EIA KIT |
| 14 |
BARTELS RSV MONOCLONAL DFA KIT |
BARTELS RSV MONOCLONAL DFA KIT |
| 15 |
BIOCLOT LA |
BIOCLOT LA |
| 16 |
CALIBRATOR |
BILE ACID CALIBRATOR |
| 17 |
CHLAMYDIA TRACHOMATIS CULTURE CONFIRMATION REAGENT |
MICROTRAK CHLAMYDIA TRACHOMATIS CULTURE CONFIRMATION TEST |
| 18 |
CHOLYLGLYCINE TEST SYSTEM |
BILE ACID KIT, BILE ACID REAGENT A, BILE ACID REAGENT B, BILE ACID STOP REAGENT |
| 19 |
COLLECTION KIT CHLAMYDIA TRACHOMATIS |
VARIOUS MICROTRAK SPECIMEN COLLECTION KITS |
| 20 |
COLLECTION KIT HSV 1 & 2 DIRECT |
VARIOUS MICROTRAK SPECIMEN COLLECTION KITS |
| 21 |
DIRECT SPECIMENT TEST FOR CHLAMYDIA TRACHOMATIS |
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST |
| 22 |
FACTOR DEFICIENCY TESTS AND CONTROLS |
BMX ALPHA-2-ANTIPLASMIN, BMX PROTEIN C, MDA PROTEIN C |
| 23 |
FACTOR II DEFICIENT, FACTOR V DEFICIENT, FACTOR VII DEFICIENT, FACTOR VII |
FACTOR II DEFICIENT, FACTOR V DEFICIENT, FACTOR VII DEFICIENT, FACTOR VII |
| 24 |
FIBRINOGEN ASSAY KIT; BOVINE THROMBIN; BOVINE THROMBIN (10 N/H UT/ML) |
FIBRINOGEN ASSAY KIT; BOVINE THROMBIN; BOVINE THROMBIN (10 N/H UT/ML) |
| 25 |
G-6-PDH KIT |
GLUCOSE-6-PHOSPHATE DEHYDROGENASE KIT, G-6-PDH SUBSTRATE POTASSIUM DICHROMATE |
| 26 |
GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING |
G-6-PDH SCREENING TEST KIT |
| 27 |
HRP; NCCP |
HEMOSTASIS REFERENCE PLASMA; NORMAL COAGULATION CONTROL PLASMA |
| 28 |
IN VITRO KIT FOR THE DETECTION OF INFLUENZA ANTIGENS |
BASTEB INFLUENZA A AG EIA |
| 29 |
INDIVIDUAL COMPONENT FOR VRK KIT |
BARTELS VRK KIT |
| 30 |
INDIVIDUAL COMPONENT FOR VRK KIT |
BARTELS VRK KIT |
| 31 |
INDIVIDUAL GENERIC COMPONENTS FOR VRK KIT |
BARTELS VRK KIT |
| 32 |
ISOLATION AND CULTURE MEDIA |
BARTELS ISOLATION AND CULTURE MEDIA |
| 33 |
LACTIC ACID TEST SYSTEM |
LACTATE REAGENT, LACTATE STANDARDS |
| 34 |
MDA D-DIMER |
MDA D-DIMER |
| 35 |
MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA |
MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA |
| 36 |
MINUTEX D-DIMER LATEX TEST |
MINUTEX D-DIMER LATEX TEST |
| 37 |
NEISERRIA GONORRHOEAE CULTURE CONFIRMATION TEST |
MICROTRAK NEISERRIA GONORRHOEAE CULTURE CONFIRMATION TEST |
| 38 |
OXALATE TEST SYSTEM |
OXALATE KIT, OXALATE REAGENT A, OXALATE REAGENT B,OXALATE STANDARDS, SAMPLE DIL |
| 39 |
PARTIAL THROMBOPLASTIN TEST CONTROLS |
APCR-QUIK TEST |
| 40 |
PARTIAL THROMBOPLASTIN TIME TEST AND CONTROL |
MDA PLATELIN LS, PLATELIN LS |
| 41 |
PLASMINOGEN TEST AND CONTROL |
MDA PLASMINOGEN, PLASMINOGEN CONTROL |
| 42 |
PROTHROMBIN TIME (PT) TEST |
MDA SIMPLASTIN HTF,SIMPLASTIN HTF,SIMPLASTIN EXCEL, SIMPLASTIN EXCEL S, MDA SIM |
| 43 |
RAPID HIV TEST |
NI-GOLD RECOMBIGEN HIV |
| 44 |
RAPID TEST FOR THE DETECTION OF H. PYLORI |
UNI-GOLD H. PYLORI |
| 45 |
RAPID TEST FOR THE DETECTION OF STREP A ANTIGEN |
UNI-GOLD STREP A TEST KIT |
| 46 |
REAGENT, THROMBOPLASTIN AND CONTROL |
THROMBOMAX HS WITH CALCIUM |
| 47 |
REFERENCE PLASMAS |
VERIFY REFERENCE PLASMA, MDA VERIFY REFERENCE |
| 48 |
RISTOCETIN; PLATELET AGGREGATION REAGENTS |
RISTOCETIN; PLATELET AGGREGATION REAGENTS |
| 49 |
SINGLE ANALYTE CONTROLS |
BILE ACID CONTROL TEST |
| 50 |
STREPTOCOCCUS SPP. SEROLOGICAL REAGENTS |
UNI-FOLD STREP A TEST KIT |
| 51 |
TEST, FIBRINOGEN |
OWRENS BUFFER |
| 52 |
THROMBIN TIME TEST AND CONTROLS |
FIBRIQUIK: MDA, KIT, CALRET, THROM REAG, OV BUFFER, THROMBOQUIK, MDA THROMBOQUIK |
| 53 |
THROMBONOSTIKA |
THROMBONOSTIKA |
| 54 |
UNI-GOLD HCG |
UNI-GOLD HCG |
| 55 |
URINALYSIS CONTROLS |
OXALATE URINE CONTROLS |
| 56 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 57 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 58 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP) PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 59 |
VARIOUS ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 60 |
VARIOUS ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 61 |
VARIOUS TRANSPORT MEDIAS |
BASTEB FLEX TRANS |
| 62 |
VARIOUS TYPES OF TSH ENZYME IMMUNOASSAYS |
MULTIPLE PRODUCT NAMES |
| 63 |
VENOM TIME REAGENT; FDP COLLECTION TUBES |
VENOM TIME REAGENT; FDP COLLECTION TUBES |
| 64 |
VERICAL SET |
VERICAL SET |
| 65 |
VERICAL SET |
VERICAL SET |
| 66 |
VERIFY 1,2,3 VERIFY I, II, III, MDA VERIFY I, II, III, REFERENCE PLASMAS |
VERIFY 1,2,3 VERIFY I, II, III, MDA VERIFY I, II, III, REFERENCE PLASMA |
| 67 |
VERIFY LOW FIBRINOGEN CONTROL |
VERIFY LOW FIBRINOGEN CONTROL |
| All FDA-Registered products for this company are displayed above. |
Other Products Offered by TRINITY BIOTECH, PLC:
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No products have been listed by this company.
Services Offered by the TRINITY BIOTECH, PLC:
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No services have been listed by this company. |
Additional Contact Information for TRINITY BIOTECH, PLC:
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| There is no additional contact information for this company. |
Companies Related to TRINITY BIOTECH, PLC
Our records indicate that the following companies are related by ownership.
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