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Last updated

18.09.2026 15:42

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Device

3108040

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Active filter:Manufacturer SRN:RO-MF-000010877

13 device results listed.

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FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED

FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080133
Basic UDI-DI
5944759080VTFOB25FECPB62B
Reference
VT-FOB-25
EMDN
W0101060399
EMDN description
FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080126
Basic UDI-DI
5944759080VTCDABGDH25B6X8
Reference
VT-CDABGDH-25
EMDN
W0105011803
EMDN description
C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse

RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080119
Basic UDI-DI
5944759080VTRSVA25STNB68G
Reference
VT-RSVA-25
EMDN
W01021699
EMDN description
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse

Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080096
Basic UDI-DI
5944759080VTSTA25STSMB6Y7
Reference
VT-STA-25
EMDN
W0105090103
EMDN description
STREP. A - RT & POC
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta

Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080089
Basic UDI-DI
5944759080VTRACG25FECB64H
Reference
VT-RAC-25
EMDN
W0101060399
EMDN description
FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta

HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080072
Basic UDI-DI
5944759080VTHAVM25SPCB6JW
Reference
VT-HAVM-25
EMDN
W01021699
EMDN description
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta

Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080065
Basic UDI-DI
5944759080VTGIAG25FECB6XK
Reference
VT-GIA-25
EMDN
W0101060399
EMDN description
FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta

Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080058
Basic UDI-DI
5944759080VTSYP25WBSPC3BE
Reference
VT-SYP-25
EMDN
W0105090105
EMDN description
SYPHILIS - RT & POC
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA

Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080041
Basic UDI-DI
5944759080VTMLD1225USB6V3
Reference
VT-MLD12-25
EMDN
W0102160511
EMDN description
MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta

Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080034
Basic UDI-DI
5944759080VTENTG25FECB6FW
Reference
VT-ENT-25
EMDN
W0101060399
EMDN description
FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA

Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080027
Basic UDI-DI
5944759080VTMLD1825USB6Y9
Reference
VT-MLD18-25
EMDN
W0102160511
EMDN description
MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080010
Basic UDI-DI
5944759080VTHPB25SPROB6HC
Reference
VT-HPBSP-25
EMDN
W0105090102
EMDN description
H. PYLORI - RT & POC
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details
TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)

HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
VitroBioChem SRL
Manufacturer SRN
RO-MF-000010877
UDI-DI
05944759080003
Basic UDI-DI
5944759080VTHPG25STO1B6H5
Reference
VT-HPG-25
EMDN
W0105010401
EMDN description
H. PYLORI ANTIGEN DETECTION
First on market country
Romania
Authorised representative
-
Last updated
31.07.2026 16:25
Manufacturer productsView details