HSA · registration DE0510186LGC Clinical Diagnostics VALIDATE® CM2 Calibration Verification / Linearity Test Kit
SingaporeClinical chemistryClass CLGC Clinical Diagnostics, Inc
Official record identity
- Registration number
- DE0510186
- Model name
- VALIDATE® CM2 Test Set
- Model identifier
- 402ab
- Registration date
- December 30, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- LGC Clinical Diagnostics, Inc
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Official description
VALIDATE CM2 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: brain natriuretic peptide (BNP), high sensitivity C- reactive protein (hs-CRP) and Troponin I (Tnl).
Additional source fields
- Product owner address
- 221 US-1, Cumberland Foreside, ME, USA, 04110, United States
- Registrant address
- 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.