Home GUDID 04262400021047 Etzel I
Primary DI 04262400021047
Brand Etzel I
Company Bio-Gram Diagnostics GmbH
Model 1
Catalog number IVD2210104
Device description Automated System for preparing sample smears on slides. For use by healthcare professionals on smearing human specimens for in vitro-diagnostic-use.
Published 2026-10-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name GKJ Spinner, Slide, Automated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GKJ Spinner, Slide, Automated Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14262400021037 Package GS1 1 In Commercial Distribution 04262400021047 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14262400021037 14262400021037 04262400021047 04262400021047 4262400021047
GMDN Terms# Term, Definition table Term Definition Microscope slide maker IVD An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue, cytology specimens, or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 0 0
Regulatory Flags# DUNS number 343065489 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04262400021030 ColorJet Nano 1 IVD2203103 2026-10-20 04262400021054 Bio-Gram Microscope Slides 1 IVD2301105 2026-10-20
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