FDA.reportPublic FDA data

Maglumi 2000 Immunoassay Analyzer

Primary DI
06947145582746
Brand
Maglumi 2000 Immunoassay Analyzer
Company
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Model
23020006
Catalog number
23020006
Published
2022-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162698000MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2017-07-14JLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947145582746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947145582746069471455827466947145582746

GMDN Terms#

Term, Definition table
TermDefinition
Chemiluminescent immunoassay analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.

Regulatory Flags#

DUNS number
421745241
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer0101010035010101010035012026-05-15
06947145547479MAGLUMI 25-OH Vitamin D130761601M130761601M2026-05-15
06947145547486MAGLUMI 25-OH Vitamin D130661601M130661601M2026-05-15
06947145547554MAGLUMI 25-OH Vitamin D130261601M130261601M2026-05-15
06947145578039MAGLUMI 2000 HCG/beta-HCG130602022M130602022M2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCG130202022M130202022M2024-05-11
06947145578053MAGLUMI 2000 25-OH Vitamin D130211007M130211007M2023-05-17
06947145578060MAGLUMI 2000 25-OH Vitamin D130611007M130611007M2023-05-17
06947145500016MAGLUMI 2000 TSH130203013M130203013M2022-08-02
06947145500023MAGLUMI 2000 TSH130603013M130603013M2022-08-02
06947145577971MAGLUMI 2000 FT4130603016M130603016M2022-08-02
06947145577988MAGLUMI 2000 FT4130203016M130203016M2022-08-02

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