INSTRUMENTATION LABORATORY COMPANY
United States US-MF-000035586 Last updated 25 Oct 2026
- Devices
- 903
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 1010 ongoing
Catalogue
HemosIL Silica Clotting Time Ref K253957
GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005 Ref 00055415005
GEM CVP (Calibration Validation Product) Level 4 00024001814 Ref 00024001814
HemosIL Liquid Heparin 00020300100 Ref 00020300100
HemosIL RecombiPlasTin 2G (8 mL) 00020002950 Ref 00020002950
HemosIL Factor V Reagent Plasma (for APC R V) 00020008800 Ref 00020008800
ChemSTAT Hematocrit Evaluator 1 00044000104 Ref 00044000104
Coatest SP FVIII 82 4086 63 Ref 82 4086 63
GEM Premier 3000 iQM - BG HCT ELECT. - 75 Tests 00024307587 Ref 00024307587
GEM Premier 3500 3000 iQM BG HCT (300 TEST) 00026330084 Ref 00026330084
Flame photometer standard 140 Na 5K 00009751750 Ref 00009751750
GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST 00055407510 Ref 00055407510
HemosIL Reference Emulsion 0009756900 Ref 0009756900
GEM Premier 3000 iQM - BG HCT ELECT. - 450 Tests 00024345087 Ref 00024345087
GEM Premier 3000 iQM - BG HCT - 300 Tests 00024330084 Ref 00024330084
Gem 4000 Pak Bg Coox 150 Test 30 Day 00027415004 Ref 00027415004
Gem 4000 Pak Bg Ise Gl Coox Bili 450 Test 30 Day 00027445011 Ref 00027445011
Optical Qc Filters 06320480221 Ref 06320480221
Avox-4 CO-Oximeter Control - L1 0003310100 Ref 0003310100
HemosIL Rinse Solution (ACL TOP Family) 00020009700 Ref 00020009700
GEM Premier 7000 with iQM3 PAK (BG/COOX 600 Tests) 00077360004 Ref 00077360004
Temperature Probe 06320480210 Ref 06320480210
GEM critCheck 0002309 Ref 0002309
Gem 4000 Pak Bg Ise Gl Coox 75 Test 30 Day 00027407510 Ref 00027407510
HemosIL Reference Emulsion 00009756900 Ref 00009756900
ChemSTAT System Evaluator 3 00044000103 Ref 00044000103
Coatest APCR Control Plasma Level 2 82 2668 63 Ref 82 2668 63
Hemosil Rivaroxaban Controls 0020015500 Ref 0020015500
HemosIL Rinse Solution (ACLFutura Advance) 00020302500 Ref 00020302500
GEM CVP (Calibration Valuation Product) 1 with CO-OX 00025000115 Ref 00025000115
Gem 4000 Pak Bg Ise Coox Bili 600 Test 21 Day 00027360009 Ref 00027360009
HemosIL PT-Fibrinogen 00009756710 Ref 00009756710
Gem 4000 Pak Bg Ise Coox Bili 450 Test 30 Day 00027445009 Ref 00027445009
Cal Dye Reference Standard 00003315050 Ref 00003315050
GEM Check Coag Control-Abnormal for Citrate PT 06260061400 Ref 06260061400
GEM Premier 3000 iQM - BG HCT ELECT. - 300 Tests 00024330087 Ref 00024330087
GEM Premier 3000 - BG HCT - 150 Tests 00024315004 Ref 00024315004
ChemSTAT System Evaluator 2 00044000102 Ref 00044000102
Gem 4000 Bak Bg Ise Coox Bili 150 Test 30 Day 00027415009 Ref 00027415009
GEM Premier 5000 PAK BG/COOX 75 TEST 00055407504 Ref 00055407504
Acl Top 300 Cts 00000280060R Ref 00000280060R
ContrIL 7 Level 3 00024001383 Ref 00024001383
GEM Hematocrit Evaluator 1 00025000104 Ref 00025000104
Control Plasma LMW Heparin 82 3492 63 Ref 82 3492 63
GEM Check Coag Control-Abnormal for PT 06260061700 Ref 06260061700
Showing 1-50 of 903
EUDAMED certificates
Notified body 2797 3 certificates
- IVDR 727616 Reissued
Quality management system EU IVDR
- Issued
- 25 Sep 2026
- Expires
- 31 Oct 2031
- Valid from
- 1 Nov 2026
- IVDR 727654 Reissued
Technical documentation EU IVDR
- Issued
- 25 Sep 2026
- Expires
- 31 Oct 2031
- Valid from
- 1 Nov 2026
- IVDR 727804 Reissued
Technical documentation EU IVDR
- Issued
- 25 Sep 2026
- Expires
- 31 Oct 2031
- Valid from
- 1 Nov 2026
Related companies
Authorised representatives
Notified bodies
- Notified body 2797
FDA recalls
2026
- 3 Sep 2026 Z-0001-2027 Not yet classified Ongoing Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- 3 Sep 2026 Z-0002-2027 Not yet classified Ongoing Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- 21 May 2026 Z-2899-2026 Class II Ongoing The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
- 21 May 2026 Z-2900-2026 Class II Ongoing The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
- 8 May 2026 Z-2821-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 8 May 2026 Z-2822-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 8 May 2026 Z-2823-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 8 May 2026 Z-2824-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 8 May 2026 Z-2825-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- 8 May 2026 Z-2826-2026 Class II Ongoing Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
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.
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