Is this your brand? Sign in to claim ownership.

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 4 of 19

Device	Model / Reference	Registries	Class	Status
GEM Premier 5000 PAK BG COOX (600 TEST)	00055360004XC	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST	00055360010	FDA UDI	Class II	Active
GEM Premier 3000 - BG HCT ELECT. GL - 150 Tests	00024315009	FDA UDI	Class II	Unknown
HemosIL HIT-Ab(PF4-H) Controls	00020014700	FDA UDI	Class II	Active
GEM Check Coag Control-Normal for Citrate PT	06260061100	FDA UDI	Class II	Unknown
Electronic Verification Cartridge Kit	06260020000	FDA UDI	Class II	Unknown
GEM Premier 5000 PAK BG/ISE/COOX 600 TEST	00055360008	FDA UDI	Class II	Active
Avox-4 CO-Oximeter Control	0003310350	FDA UDI	Class I	Active
Gem Opl (220v)	06320480001	FDA UDI	Class I	Unknown
Gem 4000 Pak Bg Ise Gl Coox Bili 75 Test 30 Day	00027407511	FDA UDI	Class II	Active
Hct Check - Low Level	00009832350	FDA UDI	Class II	Unknown
GEM Premier 5000 PAK BG COOX TBILI (450 TEST)	00055445005XC	FDA UDI	Class II	Active
GEM ChemSTAT PVP 1-5	00044001515	FDA UDI	Class I	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)	00077445010	FDA UDI	Class II	Active
GEM Premier 3500 3000 iQM BG LYTES GL (300 TEST)	00026330089	FDA UDI	Class II	Active
HemosIL D-Dimer HS 500 Controls (Liquid)	0022550030	FDA UDI	Class II	Active
Acl Top 750 Las	00000280035	FDA UDI	Class II	Active
ContrIL Spectrum Control, Level 1	00009833750	FDA UDI	Class I	Unknown
Gem 4000 Pak Bg Ise Gl Coox 150 Test 30 Day	00027415010	FDA UDI	Class II	Active
GEM CVP (Calibration Valuation Product) 2 with CO-OX	00025000125	FDA UDI	Class I	Active
Coatest APC Resistance V	82 3120 63	FDA UDI	Class II	Active
HemosIL Routine Control Level 2	00020005700	FDA UDI	Class I	Active
GEM Premier 3000 iQM - BG HCT - 75 Tests	00024407584	FDA UDI	Class II	Active
Acl Top 500 Cts	00000280040	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests)	00077407511	FDA UDI	Class II	Active
GEM Premier 3500 3000 iQM BG HCT (75 TEST)	00026407584	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE GL COOX TBIL (300 TEST)	00055430011XC	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG ISE COOX (600 TEST)	00055360008XC	FDA UDI	Class II	Active
GEM Premier 3000 - BG HCT ELECT. - 600 Tests	00024360007	FDA UDI	Class II	Unknown
GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 150 Tests)	00077415005	FDA UDI	Class II	Active
HemosIL Liquid Anti-Xa	00020302600	EUDAMEDFDA UDI	Class II	Active
ContrIL 9 Level 3	00024001421	FDA UDI	Class I	Active
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2	00044307510	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT ELECT. GL - 150 Tests	00024315089	FDA UDI	Class II	Active
Gem 4000 Pak Bg Ise Gl Coox Bili 150 Test 30 Day	00027415011	FDA UDI	Class II	Active
ELECTRACHROME Factor VIII	049730503	FDA UDI	Class II	Active
GEM System Evaluator 3	00025000103	FDA UDI	Class I	Active
GEM Premier 3500 3000 iQM BG LYTES (450 TEST)	00026345087	FDA UDI	Class II	Active
Coatest SP4 FVIII	82 4094 63	FDA UDI	Class II	Active
GEM ChemSTAT critPVP 1-4	00044001516	FDA UDI	Class II	Active
GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 75 Tests)	00077407505	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT ELECT - 75 Tests	00024407587	FDA UDI	Class II	Active
GEM Premier 3000 iQM - BG HCT ELECT. GL - 600 Tests	00024360089	FDA UDI	Class II	Active
GEM CVP (Calibration Valuation Product) 5 tBili	00025000145	FDA UDI	Class I	Active
GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST	00055407505	FDA UDI	Class II	Active
Coagulation Optic	00009758050	FDA UDI	Class II	Active
Gem 4000 Pak Bg Ise Coox 450 Test 30 Day	00027445008	FDA UDI	Class II	Active
Coagulation Optic (Advance)	00009758080	FDA UDI	Class II	Unknown
HemosIL D-Dimer Controls	00020008610	FDA UDI	Class II	Active
GEM Premier 5000 PAK BG COOX TBILI (600 TEST)	00055360005XC	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Instrumentation Laboratory SpA IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.