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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKJSpinner, Slide, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKJSpinner, Slide, AutomatedHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14262400021037PackageGS11In Commercial Distribution
04262400021047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426240002103714262400021037
04262400021047042624000210474262400021047

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker IVDAn 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
TypeLowHighCondition
Storage Environment Humidity00

Contacts#

Phone, Email table
PhoneEmail
+19843550399bio-gram@mddoptions.com

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 DIBrandModelCatalogPublished
04262400021030ColorJet Nano1IVD22031032026-10-20
04262400021054Bio-Gram Microscope Slides1IVD23011052026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177194694RAL SmearBoxR.A.L. DIAGNOSTICSGKJ2026-07-10
00860010522301HemaprepJ P Gilbert Company IncGKJ2023-10-13
00380740071899CELL-DYNABBOTT LABORATORIESGKJ2023-08-25
07350040976753HemaPrepCellavision ABGKJ2023-01-06
15099590330620LH SlidemakerBeckman Coulter, Inc.GKJ2020-08-31
07350040972304HemaPrepCellavision ABGKJ2018-11-07
15099590192679UniCel DxHBeckman Coulter, Inc.GKJ2016-09-23