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192 device results listed.

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TRUPCR® PML-RARA Kit - Quantitative

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304538
Basic UDI-DI: 89080153043B1259LH
Reference: 3B1259
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Kit - Quantitative Major (WHO IS)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304453
Basic UDI-DI: 89080153043B1265LC
Reference: 3B1251
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MPN Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304422
Basic UDI-DI: 89080153043B1303KT
Reference: 3B1303
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MPL Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304408
Basic UDI-DI: 89080153043B1305KX
Reference: 3B1305
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® CALR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304385
Basic UDI-DI: 89080153043B1351L6
Reference: 3B1351
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® JAK 2 QT Kit (Allele Burden)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304361
Basic UDI-DI: 89080153043B1248LC
Reference: 3B1248
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® JAK 2 Mutations Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304347
Basic UDI-DI: 89080153043B1246L8
Reference: 3B1246
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HPV HR with 16 & 18 Differentiation Kit

3B1439C

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304224
Basic UDI-DI: 89080153043B1439CM4
Reference: 3B1439C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: France
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® MGMT Methylation Detection Kit

3B1339

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304217
Basic UDI-DI: 89080153043B1339LG
Reference: 3B1339
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® STD Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304132
Basic UDI-DI: 89080153043B291NQ
Reference: 3B291/C
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BRAF Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304125
Basic UDI-DI: 89080153043B1287LN
Reference: 3B1287
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor & Micro

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304088
Basic UDI-DI: 89080153043B1267LG
Reference: 3B1267
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® IDH1/2 Detection & Differentiation Kit

3B1338

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304033
Basic UDI-DI: 89080153043B1338LE
Reference: 3B1338
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL1 Minor Quantitative Kit

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304026
Basic UDI-DI: 89080153043B1291LD
Reference: 3B1291
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:06

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BCR-ABL Kit – Qualitative Major, Minor & Micro

TRUPCR® BCR-ABL1 Qualitative Kit – Major, Minor & Micro

IVD Class CIVDR 2017/746On the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930740
Basic UDI-DI: 89080153043B1205KS
Reference: 3B1205/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® C-Kit Mutation Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930726
Basic UDI-DI: 89080153043B1341L3
Reference: 3B1341
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® CXCR4 Mutations Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930689
Basic UDI-DI: 89080153043B1425LA
Reference: 3B1425/C
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Leptospira Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930658
Basic UDI-DI: 89080153043B249NR
Reference: 3B249/C
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® PIK3CA Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930634
Basic UDI-DI: 89080153043B1345LB
Reference: 3B1345
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Leukemia Fusion Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930603
Basic UDI-DI: 89080153043B1404L2
Reference: 3B1404
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details