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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 2 of 19

Device	Model / Reference	Registries	Class	Status
GEM Premier 3500 3000 iQM BG HCT PAK (35 TEST)	00026403584	FDA UDI	Class II	Active
Barcode wand	0005312	FDA UDI	Class II	Active
GEM Premier 3500 3000 iQM BG LYTES GL (75 TEST)	00026307589	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG COOX (150 TEST)	00055415004XC	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TEST	00055360009	FDA UDI	Class II	Active
HemosIL ReadiPlasTin (10 mL)	00020301300	FDA UDI	Class II	Unknown
ContrIL 9 Level 2	00024001420	FDA UDI	Class I	Active
GEM Premier 3500 3000 iQM BG LYTES (75 TEST)	00026407587	FDA UDI	Class II	Active
GEM Premier 3000 iQM BG ILYTES PAK (75 TEST)	00024307507	FDA UDI	Class II	Unknown
GEM Premier 3500 3000 iQM BG LYTES GL (600 TEST)	00026360089	FDA UDI	Class II	Active
HemosIL Routine Control Level 1	00020005600	FDA UDI	Class I	Active
Gem 4000 Pak Bg Ise Gl Coox Bili 300 Test 30 Day	00027430011	FDA UDI	Class II	Active
ContrIL Spectrum Control, Level 3	00009833850	FDA UDI	Class I	Unknown
GEM ChemSTAT CVP 1	00044000115	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG ISE COOX (75 TEST)	00055407508XC	FDA UDI	Class II	Active
Hct Check - High Level	00009832450	FDA UDI	Class II	Unknown
GEM Premier 3500 3000 iQM BG LYTES GL (450 TEST)	00026345089	FDA UDI	Class II	Active
Flame photometer standard 140 Na 5K 1Li	00003331350	FDA UDI	Class I	Unknown
Calibration Plasma LMW Heparin	82 3500 63	FDA UDI	Class II	Active
Coamatic LR Antithrombin	82 2957 63	FDA UDI	Class II	Unknown
GEM Premier 3000 iQM - BG HCT ELECT. GL - 300 Tests	00024330089	FDA UDI	Class II	Active
Acl Top 500 Cts	00000280040R	FDA UDI	Class II	Active
GEM CVP (Calibration Valuation Product) 4 Hematocrit	00025000140	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE COOX TBILI (75 TEST)	00055407509XC	FDA UDI	Class II	Active
GEM Premier 3000 BG HCT PAK (75 TEST)	00024307504	FDA UDI	Class II	Unknown
GEM Premier 5000 PAK BG ISE COOX TBILI (450 TEST)	00055445009XC	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests)	00077415009	FDA UDI	Class II	Active
GEM Check Coag Control-Abnormal for APTT	06260060100	FDA UDI	Class II	Unknown
Multi-4 CO-Oximeter Control, Level 3	00003313250	FDA UDI	Class I	Active
HemosIL Apixaban Calibrators	0020015200	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT ELECT. GL - 450 Tests	00024345089	FDA UDI	Class II	Active
Gem 4000 Pak Bg Ise Gl Coox 600 Test 21 Day	00027360010	FDA UDI	Class II	Active
GEM Test APTT Cartridges	06260034000	FDA UDI	Class II	Unknown
Gem 4000 Pak Bg Coox Bili 150 Test 30 Day	00027415005	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/COOX 300 Tests)	00077430004	FDA UDI	Class II	Active
GEM CVP (Calibration Validation Product) Level 1	00024001811	FDA UDI	Class I	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)	00077445011	FDA UDI	Class II	Active
GEM System Evaluator 1	00025000101	FDA UDI	Class I	Active
GEM Premier 7000 with iQM3 PAK (BG/COOX 450 Tests)	00077445004	FDA UDI	Class II	Active
GEM CVP (Calibration Valuation Product) 3 Hematocrit	00025000130	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/COOX 300 TEST	00055430004	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT ELECT. - 600 Tests	00024360087	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE GL COOX (450 TEST)	00055445010XC	FDA UDI	Class II	Active
ContrIL 7 Level 2	00024001382	FDA UDI	Class I	Unknown
Multi-4 CO-Oximeter Control, Level 1	00003315250	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG ISE GL COOX TBILI (150 TEST)	00055415011XC	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT - 35 Tests	00024403584	FDA UDI	Class II	Active
GEM Check Coag Control-Normal for ACT	06260060500	FDA UDI	Class II	Unknown
Acl Top 700	00000280010R	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE COOX TBILI (300 TEST)	00055430009XC	FDA UDI	Class II	Active

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