FDA Registration
Active
🇺🇸 United States
GEM CVP 1 with CO-OX (Orangeburg NY Facility)
Reg #: 1217183
·
FEI: 1217183
·
Expires 2025
Products
15
Proprietary Names
7
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- INSTRUMENTATION LABORATORY CO.
- Registration Number
- 1217183
- FEI Number
- 1217183
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 180 Hartwell Rd.
- City
- Bedford
- State
- MA
- ZIP
- 01730
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112995
Owner / Operator
- Firm Name
- Instrumentation Laboratory Co.
- Operator Number
- 1217183
- Address
- 180 Hartwell Road, --
- City
- Bedford
- State
- MA
- Postal Code
- 01730
- Country
- US
- Correspondent
- Carol - Marble
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Acid, Lactic, Enzymatic Method | KHP | Class 1 | Clinical Chemistry | No | 2012-12-26 |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | Class 1 | Clinical Chemistry | No | 2012-12-26 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Instrument, Hematocrit, Automated | GKF | Class 2 | Hematology | No | 2012-12-26 |
| Diazo Colorimetry, Bilirubin | CIG | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2012-12-26 |
| Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | CHL | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Electrode, Ion Specific, Calcium | JFP | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2012-12-26 |
| Assay, Carboxyhemoglobin | GHS | Class 2 | Hematology | No | 2012-12-26 |
| Oximeter To Measure Hemoglobin | GLY | Class 2 | Hematology | No | 2012-12-26 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2012-12-26 |
| Control, Hematocrit | GLK | Class 2 | Hematology | No | 2012-12-26 |
Proprietary Names
GEM CVP 1 with CO-OX (Orangeburg NY Facility)
GEM CVP 3 Hematocrit (Orangeburg NY Facility)
GEM CVP 5 tBili (Orangeburg NY Facility)
GEM Premier 4000 (Bedford MA Facility)
GEM Premier 4000 PAK (Bedford MA Facility)
GEM CVP 4 Hematocrit (Orangeburg NY Facility)
GEM CVP 2 with CO-OX (Orangeburg NY Facility)
Establishment Types
Manufacture Medical Device