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3B BlackBio Dx Limited

India·IN-MF-000023698

Last updated September 18, 2026

About

3B BlackBio is a leading PCR kit manufacturer in India & molecular diagnostic kit supplier. Counted among trusted molecular diagnostic companies, we are a reliable PCR kit manufacturer, PCR test manufacturer and real time PCR kits supplier, offering advanced solutions to setup PCR testing with accuracy

From the manufacturer's own website. Source

What 3B BlackBio Dx Limited makes

3B BlackBio Dx Limited manufactures real-time PCR detection kits for infectious diseases, genetic mutations, and bacterial/fungal DNA extraction. Their products include kits for identifying vancomycin-resistant enterococci (VRE), JAK2 mutations, HLA-B27, NPM1 mutations, and rifampicin/isoniazid-resistant Mycobacterium tuberculosis. Additional offerings cover multiplex panels for meningitis, influenza A/B and respiratory syncytial virus (RSV), and SARS-CoV-2 detection, as well as quantitative assays for MPL mutations and MPN gene panels.

The company’s portfolio spans in vitro diagnostic (IVD) device classes A, B, C, and the general IVD category. Their products are registered in the EU’s eudamed database, a centralised registry for medical devices authorised under EU regulations. The manufacturer is based in India.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
India
Address
Govindpura, 7-C, Industrial Area, Bhopal, India
Phone
+91 755 4076518
PRRC Contact
Shirish Koshti
EUDAMED SRN
IN-MF-000023698
FDA FEI Number
—
DUNS Number
—

Catalogue (65)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
TRUPCR® Panel Extraction Kit 3B1401E
EUDAMED
Class AActive
TRUPCR® CALR Kit 3B1351
EUDAMED
Class CActive
TRUPCR® Neuro Panel Kit 3B240
EUDAMED
Class CActive
TRUPCR® HPV High Risk Genotyping Kit 3B1424
EUDAMED
Class CActive
TRUPCR® JAK 2 QT Kit (Allele Burden) 3B1249
EUDAMED
Class CActive
TRUPCR® Neuro Panel Kit 3B240/C
EUDAMED
Class CActive
TRUPCR® SARS-CoV-2 RT qPCR Kit 3B304
EUDAMED
Class CActive
TRUPCR® NRAS Kit 3B1274
EUDAMED
Class CActive
TRUPCR® TORCH Panel Kit 3B1272
EUDAMED
Class CActive
TRUPCR® CMV QT Kit 3B1215/C
EUDAMED
Class CActive
TRUPCR® BCR-ABL1 Kit - Quantitative Major (WHO IS) 3B1265
EUDAMED
Class CActive
TRUPCR® Total Nucleic Acid Extraction Kit (500µl) 3B213
EUDAMED
Class AActive
TRUPCR® AML Panel Kit 3B1401
EUDAMED
Class CActive
TRUPCR® HPV 16 & 18 Kit 3B1276/C
EUDAMED
Class CActive
TRUPCR® Tropical Fever Panel Kit 3B250/C
EUDAMED
Class CActive

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