Search Results
Found 4 results
510(k) Data Aggregation
K Number
K232587Device Name
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd
Date Cleared
2024-04-12
(231 days)
Product Code
MRG, JJE
Regulation Number
862.1825Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen New Industries Biomedical Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.
Device Description
MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer:
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations.
MAGLUMI 25-OH Vitamin D assay:
MAGLUMI 25-OH Vitamin D kit consists of the following reagents:
Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, NaN3 (<0.1%). Calibrator Low- A low concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Calibrator High- A high concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Buffer- Acidic buffer ABEI Label- ABEI labeled with anti-25-OH VD antibody (~0.500 ug/mL) in PBS buffer, NaN3 (<0.1%). Control 1- A low concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Control 2- A high concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%).
Ask a Question
K Number
K192547Device Name
MAGLUMI 2000 HCG/ß-HCG
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd
Date Cleared
2020-01-17
(122 days)
Product Code
DHA
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen New Industries Biomedical Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAGLUMI 2000 HCG/S-HCG is an in vitro chemiluminescence immunoassay for the quantitative determination of total beta human chorionic gonadotropin (total ß-hCG) in human serum. The measurement of total ß-hCG is used as an aid in the early detection of pregnancy.
Device Description
MAGLUMI 2000 HCG/B-HCG kit consists of the following reagents: Magnetic Microbeads- coated with anti-HCG monoclonal antibody, containing BSA, NaN3 (<0.1%) Calibrator Low-Containing BSA and HCG antigen, NaN3(<0.1%) Calibrator High- Containing BSA and HCG antigen, NaN3(<0.1%) Buffer- containing BSA, NaN3 (<0.1%) ABEI Label- Anti-HCG monoclonal antibody labeled with ABEI, containing BSA, NaN3 (<0.1%) Control 1- Containing BSA and HCG antigen, NaN3 (<0.1%) Control 2- Containing BSA and HCG antigen, NaN3 (<0.1%)
Ask a Question
K Number
K191499Device Name
MAGLUMI 2000 25-OH Vitamin D
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd
Date Cleared
2019-08-01
(56 days)
Product Code
MRG
Regulation Number
862.1825Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen New Industries Biomedical Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.
Device Description
MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (<0.1%) Calibrator Low-Containing BSA and 25-OH Vitamin D antigen, NaN3(<0.1%) Calibrator High- Containing BSA and 25-0H Vitamin D antigen, NaN3(<0.1%) Displacing Reagent- Acidic buffer ABEI Label- 25-OH Vitamin D antigen labeled with ABEI Control 1- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%) Control 2- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%)
Ask a Question
K Number
K182423Device Name
MAGLUMI 2000 FT4
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd
Date Cleared
2018-10-04
(28 days)
Product Code
CEC
Regulation Number
862.1695Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen New Industries Biomedical Engineering Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.
Device Description
MAGLUMI 2000 FT4 kit consists of the following reagents: Magnetic Microbeads- coated with T4 antigen, BSA, NaN3(<0.1%) Calibrator Low-Containing BSA and T4 antigen, NaN3 (<0.1%) Calibrator High- Containing BSA and T4 antigen, NaN3 (<0.1%) Buffer- Containing BSA and NaN3 (<0.1%) ABEI Label- Anti-T4 monoclonal antibody labeled with ABEI, containing BSA, NaN3(<0.1%) Control 1- Containing BSA and T4 antigen, NaN3 (<0.1%) Control 2- Containing BSA and T4 antigen, NaN3 (<0.1%)
Ask a Question
Page 1 of 1