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.

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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.

00845533001878 - ZEUS NTx Urine2023-04-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen
00845533001861 - ZEUS dIFine(R)2022-05-11ZEUS 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.
00845533001861 - ZEUS dIFine(R)2022-05-11 ZEUS dIFine® digital immunofluorescence system is an IFA imaging and pattern recognition instrument designed to acquire, analyz
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00845533000505 - ELISA EBV-VCA IgM Q Test System2019-02-21 The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is an enzyme-linked immunosorbent assay (ELISA)
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