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Sign in to claim this brandINSTRUMENTATION 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
- —
- —
- [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 3 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Coamatic Protein C | 82 2098 63 | FDA UDI | Class II | Unknown |
| Coamatic Heparin | 82 3393 63 | FDA UDI | Class II | Active |
| Gem 4000 Pak Bg Ise Coox Bili 75 Test 30 Day | 00027407509 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST | 00055445010 | FDA UDI | Class II | Active |
| GEM Premier 4000 | 00025000000R | FDA UDI | Class II | Active |
| Gem 4000 Pak Bg Coox 450 Test 30 Day | 00027445004 | FDA UDI | Class II | Active |
| GEM Premier 3500 3000 iQM BG LYTES (600 TEST) | 00026360087 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG ISE GL COOX (600 TEST) | 00055360010XC | FDA UDI | Class II | Active |
| HemosIL AcuStar D-Dimer | 0009802000 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG COOX TBILI (300 TEST) | 00055430005XC | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG ISE COOX (300 TEST) | 00055430008XC | FDA UDI | Class II | Active |
| GEM Premier 3000 | 0005700R | FDA UDI | Class II | Active |
| GEM System Evaluator 2 | 00025000102 | FDA UDI | Class I | Active |
| GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST | 00055430009 | FDA UDI | Class II | Active |
| HemosIL Routine Control Level 3 | 00020005800 | FDA UDI | Class I | Active |
| Gem 4000 Pak Bg Coox Bili 600 Test 21 Day | 00027360005 | FDA UDI | Class II | Active |
| HemosIL Abnormal Control 3 | 00020014100 | FDA UDI | Class II | Active |
| Temperature Verification Cartridges | 06260019000 | FDA UDI | Class II | Unknown |
| Coatest APC Resistance | 82 2643 63 | FDA UDI | Class II | Unknown |
| Chromogenic Optic (Advance) | 00009757980 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST | 00055415009 | FDA UDI | Class II | Active |
| GEM Premier 3500 3000 iQM BG HCT (450 TEST) | 00026345084 | FDA UDI | Class II | Active |
| GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 600 Tests) | '00077360005 | FDA UDI | Class II | Active |
| Gem 4000 Pak Bg Coox Bili 450 Test 30 Day | 00027445005 | FDA UDI | Class II | Active |
| Acl Top 700 | 00000280010 | FDA UDI | Class II | Active |
| HemosIL FII & FV DNA Control | 00020003500 | FDA UDI | Class II | Unknown |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 75 Tests) | 00077407509 | FDA UDI | Class II | Active |
| GEM Premier 3500 3000 iQM BG LYTES (150 TEST) | 00026315087 | FDA UDI | Class II | Active |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests) | 00077430011 | FDA UDI | Class II | Active |
| Acl Top 300 Cts | 00000280060 | FDA UDI | Class II | Active |
| Coamatic Antithrombin | 82 1991 63 | FDA UDI | Class II | Unknown |
| HemosIL Antithrombin | 00020008900 | FDA UDI | Class II | Unknown |
| Acl Top 700 Las | 00000280030 | FDA UDI | Class II | Active |
| Gem Opl Cuvettes | 06320480100 | FDA UDI | Class I | Active |
| GEM Test Citrate PT Cartridges | 06260032000 | FDA UDI | Class II | Unknown |
| Gem 4000 Pak Bg Ise Coox 150 Test 30 Day | 00027415008 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST | 00055445011 | FDA UDI | Class II | Active |
| ContrIL 9 Level 1 | 00024001419 | FDA UDI | Class I | Active |
| GEM Premier 3000 iQM - BG HCT - 600 Tests | 00024360084 | FDA UDI | Class II | Active |
| GEM Premier 7000 with iQM3 PAK (7k BG/ISE/COOX 150 Tests) | 00077415008 | FDA UDI | Class II | Active |
| Coatest APC Resistance V-S | 82 3138 63 | FDA UDI | Class II | Active |
| IL critPVP | 00024001516 | FDA UDI | Class II | Active |
| HemosIL Liquid Anti-Xa | 0020302602 | FDA UDI | Class II | Active |
| HemosIL Calcium Chloride 0.025M (for APTT-SP kit) | 00019741910 | FDA UDI | Class II | Unknown |
| GEM Hematocrit Evaluator 2 | 00025000105 | FDA UDI | Class II | Active |
| Coamatic Factor VIII | 82 2585 63 | FDA UDI | Class II | Active |
| GEM Premier 3000 - BG HCT ELECT. - 150 Tests | 00024315007 | FDA UDI | Class II | Unknown |
| Kit, 2d Barcode Acl Top | 00028210900 | FDA UDI | Class II | Active |
| GEM Premier 5000 PAK BG ISE GL COOX TBILI (75 TEST) | 00055407511XC | FDA UDI | Class II | Active |
| HemosIL Liquid Anti-Xa | 0020303600 | FDA UDI | Class II | Active |
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