FDA.reportPublic FDA data

MAGLUMI 2000 HCG/beta-HCG

Primary DI
06947145578046
Brand
MAGLUMI 2000 HCG/beta-HCG
Company
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Model
130202022M
Catalog number
130202022M
Published
2024-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DHASystem, Test, Human Chorionic Gonadotropin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHASystem, Test, Human Chorionic GonadotropinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192547000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192547000MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.2020-01-17DHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947145578046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947145578046069471455780466947145578046

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421745241
Device count
1
Lot or batch
true
Expiration 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
06947145578053MAGLUMI 2000 25-OH Vitamin D130211007M130211007M2023-05-17
06947145578060MAGLUMI 2000 25-OH Vitamin D130611007M130611007M2023-05-17
06947145582746Maglumi 2000 Immunoassay Analyzer23020006230200062022-12-31
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
00380740106003ARCHITECTABBOTT IRELANDDHA2025-12-12
20612479280124McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
10612479280172McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-12-10
00380740215712AlinityABBOTT LABORATORIESDHA2025-10-08
20612479279715McKessonMCKESSON MEDICAL-SURGICAL INC.DHA2025-09-10
10758750034291VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
20758750034298VITROSORTHO CLINICAL DIAGNOSTICSDHA2024-09-18
07613336217535Elecsys HCG+ betaRoche Diagnostics GmbHDHA2024-06-03
06947145578039MAGLUMI 2000 HCG/beta-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.DHA2024-05-11
06925912718703iFlash-HCGShenzhen YHLO Biotech Co., Ltd.DHA2024-01-30
00695684893019Pregcolor PlusGERMAINE LABORATORIES, INCDHA2023-08-09
00695684971014Pregcolor Premium GERMAINE LABORATORIES, INCDHA2023-08-09
04987270235232Lumipulse G BHCG Immunoreaction CartridgesFUJIREBIO INC.DHA2023-02-01
15099590744380Access Total BhCG (5th IS)Beckman Coulter, Inc.DHA2023-01-06
08806388243310Multi-unit Angled AbutmentMegagen Implant Co. LtdDHA2021-11-17
07613336169216Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
07613336169223Elecsys HCG Test SystemRoche Diagnostics GmbHDHA2021-09-24
00695684957018Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
06956848940166Mosie Baby Pregnancy TestGERMAINE LABORATORIES, INCDHA2019-10-21
00380740160623AlinityABBOTT IRELANDDHA2019-04-10
00816862021639PreviewWONDFO USA CO., LTD.DHA2019-03-06
00816870020570Free B-hCG XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020587Free B-hCG XR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020921hCG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020938Monobind AccuBind hCG ELISA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870020945hCG Extended Range AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870020952hCG Extended Range AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022253Monobind AccuLite Free B-hCG XR CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11
00816870022260Monobind AccuLite Free B-hCG XR CLIA Kit - 192 WellsMONOBIND, INC.DHA2019-02-11
00816870022581Monobind AccuLite hCG CLIA Kit - 96 WellsMONOBIND, INC.DHA2019-02-11