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INSTRUMENTATION LABORATORY COMPANY

United States·US-MF-000035586

Last updated September 17, 2026

What INSTRUMENTATION LABORATORY COMPANY makes

The company manufactures in vitro diagnostics (IVDs) for blood gas, haemoximetry, and electrolyte analysis, including point-of-care and laboratory kits, controls, and analysers. Products include coagulation analysers, factor VIII assays (chromogenic), D-dimer controls, and electrolyte controls. Analyser models support multiple analyte testing, such as blood gases, haematocrit, and ion-selective electrodes, with some designed for quality management (e.g., calibration validation products).

These devices are regulated under EU Class A, B, and C classifications and US FDA Class I and II, with listings in the EUDAQD (eudamed) and FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 180, Hartwell Road, Bedford, United States
Website: www.instrumentationlaboratory.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 800 678 0710
PRRC Contact: Carol Marble
EUDAMED SRN: US-MF-000035586
FDA FEI Number: 2431530
DUNS Number: 557223252

Catalogue (901)

Page 5 of 19

Device	Model / Reference	Registries	Class	Status
Hemosil Rivaroxaban Calibrators	0020015400	FDA UDI	Class II	Active
Gem 4000 Pak Bg Ise Coox Bili 300 Test 30 Day	00027430009	FDA UDI	Class II	Active
Chromogenic Optic	00009757950	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT - 75 Tests	00024307584	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE COOX TBILI (150 TEST)	00055415009XC	FDA UDI	Class II	Active
HemosIL Acustar HIT Controls	0009800131	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE GL COOX TBILI (600 TEST)	00055360011XC	FDA UDI	Class II	Active
ContrIL 7 Multipak	00024001380	FDA UDI	Class I	Unknown
GEM Premier 5000 PAK BG COOX (300 TEST)	00055430004XC	FDA UDI	Class II	Active
Il Pvp	00024001515	FDA UDI	Class I	Active
GEM ChemSTAT CVP 2	00044000125	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST	00055430010	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG COOX TBILI (75 TEST)	00055407505XC	FDA UDI	Class II	Active
GEM ChemSTAT CVP 4	00044000140	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG/COOX 150 TEST	00055415004	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 75 Tests)	00077407508	FDA UDI	Class II	Active
Chromogenic Optic 160 umol L	00097579000	FDA UDI	Class II	Active
GEM Check Coag Control-Normal for APTT	06260061600	FDA UDI	Class II	Unknown
Hct Calibrator	00009832550	FDA UDI	Class II	Unknown
GEM Premier 3000 - BG HCT ELECT. GL - 600 Tests	00024360009	FDA UDI	Class II	Unknown
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)	00077360010	FDA UDI	Class II	Active
HemosIL Chromogenic Factor IX	0020012900	FDA UDI	Class II	Active
Gem 4000 Pak Bg Coox Bili 300 Test 30 Day	00027430005	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE GL COOX (300 TEST)	00055430010XC	FDA UDI	Class II	Active
GEM Hematocrit Evaluator 3	00025000106	FDA UDI	Class II	Active
Multi-4 CO-Oximeter Control, Multi-Pack	00003316200	FDA UDI	Class I	Active
HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)	00020006900	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST	00055415011	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT - 150 Tests	00024315084	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST	00055415010	FDA UDI	Class II	Active
HemosIL Abnormal Control 2	00020014000	FDA UDI	Class II	Active
GEM Test ACT-LR Cartridges	06260040000	FDA UDI	Class II	Unknown
GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 300 Tests)	00077430005	FDA UDI	Class II	Active
HemosIL AcuStar HIT-IgG (PF4-H)	0009800127	FDA UDI	Class II	Active
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct	00044307508	FDA UDI	Class II	Active
Avox-4 CO-Oximeter Control - L3	0003310300	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG/ISE/COOX 75 TEST	00055407508	FDA UDI	Class II	Active
GEM Premier 3000 - BG HCT ELECT GL - 300 Tests	00024330009	FDA UDI	Class II	Unknown
GEM Premier 3000 iQM - BG HCT ELECT. - 150 Tests	00024315087	FDA UDI	Class II	Active
GEM CVP (Calibration Validation Product) Level 2	00024001812	FDA UDI	Class I	Active
ChemSTAT Hematocrit Evaluator 2	00044000105	FDA UDI	Class II	Active
ContrIL Spectrum Control, Level 2	00009833650	FDA UDI	Class I	Unknown
GEM Check Coag Control-Abnormal for ACT-LR	06260060200	FDA UDI	Class II	Unknown
GEM Premier 5000 PAK BG ISE GL COOX (75 TEST)	00055407510XC	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG COOX TBILI (150 TEST)	00055415005XC	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/ISE/COOX 300 TEST	00055430008	FDA UDI	Class II	Active
Gem 4000 Pak Bg Ise Gl Coox 450 Test 30 Day	00027445010	FDA UDI	Class II	Active
GEM Premier 4000	00025000000	FDA UDI	Class II	Active
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2	00044330010	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 600 Tests)	00077360009	FDA UDI	Class II	Active

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