FDA.reportPublic FDA data

ZEUS NTx Serum

Primary DI
00845533001861
Brand
ZEUS NTx Serum
Company
ZEUS SCIENTIFIC, INC.
Model
NTx9021
Device description
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human sera.
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JMMColumn Chromatography & Color Development, Hydroxyproline
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMMColumn Chromatography & Color Development, HydroxyprolineClinical Chemistry1
PIVAutomated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical UseImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533001861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001861008455330018618455330018610845533001861

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080953946
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845533003681Herpes Simplex Virus-1 (HSV-1) IgMFA9051MFA9051M2026-06-09
00845533003698Herpes Simplex Virus-2 (HSV-2) IgGFA9052GFA9052G2026-06-09
00845533003582Alegria Flash SSA-60CL28001CL280012026-06-08
00845533003599Alegria Flash SSA-60 Control KitCL28001CKCL28001CK2026-06-08
00845533003605Alegria Flash SSA-52CL28011CL280112026-06-08
00845533003612Alegria Flash SSA-52 Control KitCL28011CKCL28011CK2026-06-08
00845533003629Alegria Flash SSBCL28021CL280212026-06-08
00845533003636Alegria Flash SSB Control KitCL28021CKCL28021CK2026-06-08
00845533003643Cytomegalovirus (CMV) IgGFA9001GFA9001G2026-06-08
00845533003650Cytomegalovirus (CMV) IgMmFA9001MFA9001M2026-06-08
00845533003667Herpes Simplex Virus-1 (HSV-1) IgGFA9051GFA9051G2026-06-08
00845533003674Herpes Simplex Virus-2 (HSV-2) IgMFA9052MFA9052M2026-06-08
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
00845533003568Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgGFA9151GFA9151G2026-05-26
00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533002936NTx UrineZEUS SCIENTIFIC, INC.JMM2026-02-18
00845533002943NTx SerumZEUS SCIENTIFIC, INC.JMM2026-02-18
08059304340239dIFine ANCA ClassifierVISIA LAB SRLPIV2025-06-27
00845533002004Sebia NTx Serum Test SystemZEUS SCIENTIFIC, INC.JMM2025-06-13
00845533001960Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001977Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)ZEUS SCIENTIFIC, INC.PIV2025-05-12
00845533001953ZEUS NTx SerumZEUS SCIENTIFIC, INC.JMM2025-03-21
04260186120008HELIOS® Automated IFA SystemAesku.Diagnostics GmbH & Co. KGPIV2025-01-03
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLPIV2024-11-08
08059304340222dIFine DNA ClassifierVISIA LAB SRLPIV2024-11-08
04049016137894IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2024-09-11
05060169695986IDS Beta CrossLaps® (CTX-I)IMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2024-01-03
04049016152989IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2023-07-05
04250289512541HELIOS® AUTOMATED IFA SYSTEMAesku.Diagnostics GmbH & Co. KGPIV2023-06-25
05060169690141Urine CrossLaps® (CTX-I) EIAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2023-06-23
00845533001878ZEUS NTx UrineZEUS SCIENTIFIC, INC.JMM2023-04-18
04049016148708EUROPattern ClassifierEUROIMMUN Medizinische Labordiagnostika AGPIV2022-12-08
08059304340109dIFine Automated Microscope VISIA LAB SRLPIV2022-09-07
07613336171561Elecsys Beta-CrossLaps/serumRoche Diagnostics GmbHJMM2021-10-01
07613336187012Elecsys Beta-CrossLaps/serumRoche Diagnostics GmbHJMM2021-10-01
08426951056538NOVA Lite® DAPI dsDNA Crithidia Luciliae KitINOVA DIAGNOSTICS, INC.PIV2021-03-31
00630414953281IMMULITE® Systems PDP CONTROL Pyrilinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414954202IMMULITE®/IMMULITE® 1000 Systems DPD Pyrilinks-D Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414961859IMMULITE® 2000 Systems DPD Pyrlinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414964416IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
10811877010934Osteomark NTx UrineAlere Scarborough, Inc.JMM2020-09-16
10811877010941Osteomark NTx SerumAlere Scarborough, Inc.JMM2020-09-16
04049016107057IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPIV2020-08-28
10758750000500VITROSORTHO CLINICAL DIAGNOSTICSJMM2020-04-01
04260186125096HELIOSAesku.Systems GmbH & Co. KGPIV2020-03-02