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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
Website: www.3bblackbio.com
LinkedIn: linkedin.com/company/3b-blackbio-biotech-india-ltd
Facebook: facebook.com/3bblackbio
Email: [email protected]
Phone: +91 755 4076518
PRRC Contact: Shirish Koshti
EUDAMED SRN: IN-MF-000023698
FDA FEI Number: —
DUNS Number: —

Catalogue (65)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
TRUPCR® VRE Detection Kit	3B373	EUDAMED	Class C	Active
TRUPCR® JAK 2 Mutations Detection Kit	3B1247	EUDAMED	Class C	Active
TRUPCR® HLA-B27 Kit	3B247	EUDAMED	Class C	Active
TRUPCR® NPM1 Quantitative Kit	3B325	EUDAMED	Class C	Active
TRUPCR® MPL Kit	3B1306	EUDAMED	Class C	Active
TRUPCR® Bacterial / Fungal DNA Extraction Kit	3B345	EUDAMED	Class A	Active
TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit	3B1280/C	EUDAMED	Class C	Active
TRUPCR® MPN Panel Kit	3B1303	EUDAMED	Class C	Active
TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit	3B012/C	EUDAMED	Class C	Active
TRUPCR® JAK 2 Mutations Detection Kit	3B1246	EUDAMED	Class C	Active
TRUPCR® Meningitis Panel Kit	3B354	EUDAMED	Class C	Active
TRUPCR® Meningitis Panel Kit	3B353/C	EUDAMED	Class C	Active
TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit	3B1280	EUDAMED	Class C	Active
TRUPCR® MPL Kit	3B1305	EUDAMED	Class C	Active
TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit	3B012	EUDAMED	Class C	Active
TRUPCR® NPM1 Quantitative Kit	3B326	EUDAMED	Class C	Active
TRUPCR® PML-RARA Kit - Quantitative	3B1259	EUDAMED	Class C	Active
TRUPCR® HPV High Risk Genotyping Kit	3B1423	EUDAMED	Class C	Active
TRUPCR® Respiratory Pathogen Panel Kit	3B287/C	EUDAMED	Class B	Active
TRUPCR® KRAS Kit	3B1262	EUDAMED	Class C	Active
TRUPCR® Toxoplasma Real-Time PCR Detection Kit	3B279/C	EUDAMED	Class C	Active
TRUPCR® DPYD Mutations Detection Kit	3B1429	EUDAMED	Class C	Active
TRUPCR® Rifampicin & Isoniazid Resistant MTB Detection Kit	3B1275	EUDAMED	Class C	Active
TRUPCR® Respiratory Pathogen Panel Kit	3B288	EUDAMED	Class B	Active
TRUPCR® BCR-ABL1 Minor Quantitative Kit	3B1291	EUDAMED	Class C	Active
TRUPCR® BCR-ABL Kit - Minor Quantitative	3B1292	EUDAMED	Class C	Active
TRUPCR® BS DNA Extraction Kit	3B215	EUDAMED	Class A	Active
TRUPCR® DPYD Mutations Detection Kit	3B1429/C	EUDAMED	Class C	Active
TRUPCR® MTBC OneStep Nested Kit	3B268	EUDAMED	Class C	Active
TRUPCR® BCR-ABL Kit – Qualitative Major, Minor & Micro	3B1206	EUDAMED	Class C	Active
TRUPCR® MGMT Methylation Detection Kit	3B1340	EUDAMED	Class C	Active
TRUPCR® STD Panel Kit	3B292	EUDAMED	Class C	Active
TRUPCR® ALL Panel Kit	3B1405	EUDAMED	Class C	Active
TRUPCR® BCR-ABL1 Kit - Quantitative Major (WHO IS)	3B1252	EUDAMED	Class C	Active
TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro	3B1267	EUDAMED	Class C	Active
TRUPCR® MPN Panel Kit	3B1304	EUDAMED	Class C	Active
TRUPCR® BRAF Kit	3B1287	EUDAMED	Class C	Active
TRUPCR® NRAS Kit	3B1296	EUDAMED	Class C	Active
TRUPCR® KRAS Kit	3B1261	EUDAMED	Class C	Active
TRUPCR® Total Nucleic Acid Extraction Kit (500ul)	3B213	EUDAMED	IVD General	Active
TRUPCR® BRAF Kit	3B1288	EUDAMED	Class C	Active
TRUPCR® Neuro Panel Kit	3B239	EUDAMED	Class C	Active
TRUPCR® Bacterial / Fungal DNA Extraction Kit	3B346	EUDAMED	Class A	Active
TRUPCR® Flu Panel with RSV Detection Kit (TRUPCR® Inf A/ H1N1/ H3N2/ Inf B/ RSV Detection Kit)	3B221	EUDAMED	Class C	Active
TRUPCR® BCR-ABL1 Qualitative Kit – Major, Minor & Micro	3B1205	EUDAMED	Class C	Active
TRUPCR® IDH1/2 Detection & Differentiation Kit	3B1337	EUDAMED	Class C	Active
TRUPCR® Meningitis Panel Kit	3B353	EUDAMED	Class C	Active
TRUPCR® EGFR Kit	3B1312	EUDAMED	Class C	Active
TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor & Micro	3B1267/C	EUDAMED	Class C	Active
TRUPCR® HPV High Risk Genotyping Kit	3B1423/C	EUDAMED	Class C	Active

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