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INSTRUMENTATION LABORATORY COMPANY

United States·US-MF-000035586

Last updated September 17, 2026

Information

Country
United States
Address
180, Hartwell Road, Bedford, United States
LinkedIn
—
Facebook
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Phone
+1 800 678 0710
PRRC Contact
Carol Marble
EUDAMED SRN
US-MF-000035586
FDA FEI Number
2431530
DUNS Number
557223252

Catalogue (901)

Page 1 of 19
DeviceModel / ReferenceRegistriesClassStatus
GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005
FDA UDI
Class IIActive
GEM CVP (Calibration Validation Product) Level 4 00024001814
FDA UDI
Class IActive
HemosIL Liquid Heparin 00020300100
FDA UDI
Class IIUnknown
HemosIL RecombiPlasTin 2G (8 mL) 00020002950
FDA UDI
Class IIActive
HemosIL Factor V Reagent Plasma (for APC R V) 00020008800
FDA UDI
Class IIUnknown
ChemSTAT Hematocrit Evaluator 1 00044000104
FDA UDI
Class IIActive
Coatest SP FVIII 82 4086 63
FDA UDI
Class IIActive
GEM Premier 3000 iQM - BG HCT ELECT. - 75 Tests 00024307587
FDA UDI
Class IIActive
GEM Premier 3500 3000 iQM BG HCT (300 TEST) 00026330084
FDA UDI
Class IIActive
Flame photometer standard 140 Na 5K 00009751750
FDA UDI
Class IUnknown
GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST 00055407510
FDA UDI
Class IIActive
HemosIL Reference Emulsion 0009756900
FDA UDI
Class IIUnknown
GEM Premier 3000 iQM - BG HCT ELECT. - 450 Tests 00024345087
FDA UDI
Class IIActive
GEM Premier 3000 iQM - BG HCT - 300 Tests 00024330084
FDA UDI
Class IIActive
Gem 4000 Pak Bg Coox 150 Test 30 Day 00027415004
FDA UDI
Class IIActive
Gem 4000 Pak Bg Ise Gl Coox Bili 450 Test 30 Day 00027445011
FDA UDI
Class IIActive
Optical Qc Filters 06320480221
FDA UDI
Class IActive
Avox-4 CO-Oximeter Control - L1 0003310100
FDA UDI
Class IActive
HemosIL Rinse Solution (ACL TOP Family) 00020009700
FDA UDI
Class IIUnknown
GEM Premier 7000 with iQM3 PAK (BG/COOX 600 Tests) 00077360004
FDA UDI
Class IIActive
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 00044345008
FDA UDI
Class IIActive
Temperature Probe 06320480210
FDA UDI
Class IActive
GEM critCheck 0002309
FDA UDI
Class IIActive
Gem 4000 Pak Bg Ise Gl Coox 75 Test 30 Day 00027407510
FDA UDI
Class IIActive
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests) 00077415011
FDA UDI
Class IIActive
HemosIL Reference Emulsion 00009756900
FDA UDI
Class IIUnknown
ChemSTAT System Evaluator 3 00044000103
FDA UDI
Class IActive
Coatest APCR Control Plasma Level 2 82 2668 63
FDA UDI
Class IIActive
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests) 00077360011
FDA UDI
Class IIActive
Hemosil Rivaroxaban Controls 0020015500
FDA UDI
Class IIActive
HemosIL Rinse Solution (ACLFutura Advance) 00020302500
FDA UDI
Class IIUnknown
GEM CVP (Calibration Valuation Product) 1 with CO-OX 00025000115
FDA UDI
Class IActive
Gem 4000 Pak Bg Ise Coox Bili 600 Test 21 Day 00027360009
FDA UDI
Class IIActive
HemosIL PT-Fibrinogen 00009756710
FDA UDI
Class IIActive
Gem 4000 Pak Bg Ise Coox Bili 450 Test 30 Day 00027445009
FDA UDI
Class IIActive
Cal Dye Reference Standard 00003315050
FDA UDI
Class IIUnknown
GEM Check Coag Control-Abnormal for Citrate PT 06260061400
FDA UDI
Class IIUnknown
GEM Premier 3000 iQM - BG HCT ELECT. - 300 Tests 00024330087
FDA UDI
Class IIActive
GEM Premier 3000 - BG HCT - 150 Tests 00024315004
FDA UDI
Class IIUnknown
ChemSTAT System Evaluator 2 00044000102
FDA UDI
Class IActive
Gem 4000 Bak Bg Ise Coox Bili 150 Test 30 Day 00027415009
FDA UDI
Class IIActive
GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests) 00077360008
FDA UDI
Class IIActive
GEM Premier 5000 PAK BG/COOX 75 TEST 00055407504
FDA UDI
Class IIActive
Acl Top 300 Cts 00000280060R
FDA UDI
Class IIActive
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) 00077430010
FDA UDI
Class IIActive
ContrIL 7 Level 3 00024001383
FDA UDI
Class IUnknown
GEM Hematocrit Evaluator 1 00025000104
FDA UDI
Class IIActive
Control Plasma LMW Heparin 82 3492 63
FDA UDI
Class IIUnknown
GEM Check Coag Control-Abnormal for PT 06260061700
FDA UDI
Class IIUnknown
GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST 00055445009
FDA UDI
Class IIActive

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