Bio-Gram Diagnostics GmbH
Germany DE-MF-000032559 Last updated 23 Oct 2026
- Devices
- 22
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
Etzel I Ref IVD2210104
Gram-Polychrome JetDye-AF System Kit Ref SK2209201
FixOstar - Hema Ref RG2211056
MGG JetDye-AF System Kit Ref SK2209202
Wright JetDye-AF Ref RG2209002
JetBuffer pH 6.4 Ref RG2209028
FixOstar Ref RG2212071
Lugol's JetDye-AF Ref RG2209017
MG JetDye-AF Ref RG2209004
JetBuffer pH 6.8 Ref RG2209027
Microscope Slide Ref IVD2301105
Giemsa JetDye-AF Ref RG2209003
ColorJet Nano Ref IVD2203103
Gram-Polychrome JetDye-AF Kit Ref RG2209013
JaClean Ref RG2209031
MGG JetDye-AF Kit Ref RG2209024
JetBuffer pH 7.2 Ref RG220900
Crystal-Violete JetDye-AF Ref RG2209015
Wright-Giemsa JetDye-AF Kit Ref RG2209026
Wright-Giemsa JetDye-AF System Kit Ref SK2209203
Safranin-FX JetDye-AF Ref RG2209032
About
Since its establishment in 2019, Bio-Gram has been at the forefront of providing cutting-edge In-Vitro-Diagnostic solutions, specifically focused on smear staining and sample preparation. With an unwavering commitment to shaping the future of diagnostics through uncompromisingly high-quality systems, Bio-Gram has consistently set new standards in the industry by developing and manufacturing innovative and reliable next-generation Diagnostic Solutions, proudly bearing the mark of "Made in Germany."
What Bio-Gram Diagnostics GmbH makes
Bio-Gram Diagnostics GmbH manufactures automated and manual staining systems for cytological and hematological smear preparations, including the Etzel I, Gram-Polychrome, MGG, Wright, Lugol’s, and Giemsa JetDye-AF kits, as well as pH-buffered solutions like JetBuffer and FixOstar. Their portfolio also includes disposable microscope slides designed for laboratory use in diagnostic workflows.
All listed devices fall under EU Class A in vitro diagnostic medical devices and are registered in the EU’s eudamed database. The company is based in Germany and adheres to relevant EU regulatory requirements for diagnostic products.
Information
- Country
- Germany
- Address
- 12, Altrheinstraße , Worms, Germany
- Website
- www.bio-gram.de
- [email protected]
- Phone
- +49 621 490 844 50
- PRRC contact
- Bayram Cucu
- EUDAMED SRN
- DE-MF-000032559
- FDA FEI number
- 3044854712
- DUNS number
- 343065489