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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.JJE2026-05-15
00380740225186ARCHITECTABBOTT LABORATORIESJJE2026-05-14
00380740225193ARCHITECTABBOTT LABORATORIESJJE2026-05-14
07613336224397cobas ISE neo 1800 analytical unitRoche Diagnostics GmbHJJE2026-04-03
07613336200544cobas c 703 analytical unitRoche Diagnostics GmbHJJE2026-03-20
07613336220191cobas pro SBL c 703Roche Diagnostics GmbHJJE2026-03-20
00199874508153Spiral LaboratoriesSOCIETE ANONYME DE FABRICATION D'APPAREILS SCIENTIFIQUESJJE2026-02-10
00380740023386ARCHITECTABBOTT LABORATORIESJJE2026-01-24
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.JJE2026-01-23
00810053950098NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggHYCOR BIOMEDICAL LLCJJE2026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkHYCOR BIOMEDICAL LLCJJE2026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCJJE2026-01-20
00810053950500NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879024555NOVEOS Clam, Mercenaria mercenariaHYCOR BIOMEDICAL LLCJJE2026-01-20
00816879028010NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraHYCOR BIOMEDICAL LLCJJE2026-01-20
00380740225155ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740225162ARCHITECTABBOTT LABORATORIESJJE2026-01-03
00380740223748AlinityAbbott GmbHJJE2026-01-01
00380740224523ARCHITECTABBOTT LABORATORIESJJE2026-01-01
00380740224530ARCHITECTABBOTT LABORATORIESJJE2026-01-01