ZEUS dIFine(R) FA08IMG

GUDID 00845533001861

ZEUS dIFine® digital immunofluorescence system is an IFA imaging and pattern recognition instrument designed to acquire, analyze, display and store digital images of ZEUS IFA slides. It consists of an automated digital scanner with intelligent software.

ZEUS SCIENTIFIC, INC.

Fluorescent immunoassay analyser IVD, laboratory, automated
Primary Device ID00845533001861
NIH Device Record Key56832619-a1ee-42de-bfb8-1333fdf40484
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEUS dIFine(R)
Version Model NumberFA08IMG
Catalog NumberFA08IMG
Company DUNS080953946
Company NameZEUS SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100845533001861 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-11
Device Publish Date2022-05-03

Devices Manufactured by ZEUS SCIENTIFIC, INC.

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00845533001977 - Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed)2025-05-20 The Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) test system is an indirect immunofluorescence assay (IFA) for the qu
00845533001953 - ZEUS NTx Serum2025-03-31 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen
00845533001892 - ANA HEp-22024-12-27 The ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclea
00845533001908 - dsDNA (Crithidia l.)2024-12-27 The dsDNA (Crithidia l.) kit is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antibod
00845533001915 - Rat Kidney/Stomach Tissue2024-12-27 The Rat Kidney/Stomach Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial,
00845533001922 - Rat Kidney/Stomach/Liver Tissue2024-12-27 The Rat Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitochon
00845533001939 - Mouse Kidney/Stomach/Liver Tissue2024-12-27 The Mouse Kidney/Stomach/Liver Tissue kit is designed for the qualitative and semi-quantitative detection of antinuclear, mitoch

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