Anatolia Geneworks
by Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S. 17 variants
Ref ABXTRT, ABCMQ3, AUA24S, ABXVR1, ABMNC3, AUM32, UMG9V1, ABXVD1, ABXGV1, ABXTRB, UMG9V2, AUS448, ABXTRS, UGDR600, ABVIP1, ABMNC1, UVDR612, AE19VP, AE96WG, ABVIP2, ABVIP3, ABCMQ1, AEMTD1, ABXGD2, UGDL600, ABXTRR, ABCAP2, ABCAP1, U96NAV, UM32V2, ABMNC2, ABXBD1, AE96VN, UMTBV1, AE96VP, AEMDR1
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number868001894EXKABXTRTXW | Date15 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Bosphore EX-Tract Dry Swab RNA Extraction KitBosphore CMV Quantification KitUnio A24S Extraction & PCR Setup SystemBosphore Viral RNA Extraction Spin KitBosphore CT/NG/MG Panel Kit v1Unio M32 Extraction SystemUNIO 96 Nucleic Acid Extraction Versatile Kit MG9Bosphore Viral DNA Extraction Spin KitBosphore Nucleic Acid Extraction Versatile Spin KitBosphore COVID-19 Sampling and Viral RNA Extraction KitUNIO 448 SystemBosphore Ex-Tract Dry Swab RNA SolutionUnio Whole Blood Genomic DNA Extraction KitBosphore Viral Infections in the Immunosuppressed Panel KitUnio Viral DNA/RNA Extraction Kit 600 µlMagnesia 2448 Viral DNA/RNA Extraction Kit EPMagnesia 2448 Whole Blood Genomic DNA Extraction KitMagrev Tissue Genomic DNA Extraction KitBosphore Genomic DNA Extraction Spin Kit v2Unio Whole Blood Genomic DNA Extraction Large Volume KitBosphore Atypical CAP Panel KitUnio 96 Nucleic Acid Extraction Versatile KitUnio M32 Viral DNA/RNA Extraction KitBosphore Bacterial DNA Extraction Spin KitMagnesia 2448 Viral DNA/RNA Extraction KitUNIO M32 Viral Nucleic Acid Extraction TBMagrev Viral DNA/RNA Extraction Kit
- Model / Reference
- ABXTRT, ABCMQ3, AUA24S, ABXVR1, ABMNC3, AUM32, UMG9V1, ABXVD1, ABXGV1, ABXTRB, UMG9V2, AUS448, ABXTRS, UGDR600, ABVIP1, ABMNC1, UVDR612, AE19VP, AE96WG, ABVIP2, ABVIP3, ABCMQ1, AEMTD1, ABXGD2, UGDL600, ABXTRR, ABCAP2, ABCAP1, U96NAV, UM32V2, ABMNC2, ABXBD1, AE96VN, UMTBV1, AE96VP, AEMDR1
- Primary DI / UDI-DI
- 08680018940417, 08680018941032, 08684198020976, 08680018941902, 08684198020570, 08684198020082, 08684198020594, 08680018941896, 08680018941759, 08680018946587, 08684198020617, 08684198025155, 08680018946136, 08680018949496, 08680018942954, 08684198020556, 08684198020785, 08684198020549, 08680018946334, 08680018942961, 08680018941353, 08680018942626, 08680018941841, 08680018940721, 08684198020655, 08680018946129, 08680018943180, 08680018943173, 08680018940691, 08684198020839, 08684198020563, 08680018941919, 08680018940660, 08684198020600, 08680018940905, 08680018940851
- Basic UDI-DI
- 868001894EXKABXTRTXW, 868001894PCRHHVCMVQT100AB, 868001894EXIAUA24SQE, 868001894EXKSPNVR10004ZT, 868001894PCRSTDCNMPN100E5, 868001894EXIAUM32AH, 868001894EXKUNINA09601NF, 868001894EXKSPNVR10003ZR, 868001894EXKSPNNA10001NG, 868001894EXKABXTRBWS, 868001894EXKUNINA19201N6, 868001894STRAUS4487L, 868001894EXKDRYSW15004VQ, 868001894EXKUNIWB09601TM, 868001894PCRABVIP3SQ, 868001894EXKUVDR612VD, 868001894EXKMGSEP19202H7, 868001894EXKMGSWB04803LM, 868001894EXKMGVTS09603UH, 868001894EXKSPNGN10003Q6, 868001894EXKUNIWB09603TR, 868001894EXKDRYSW25004W3, 868001894PCRRESCAPPN1004N, 868001894EXKUNI96096017R, 868001894EXKUM32V2V4, 868001894EXKSPNBC10003H2, 868001894EXKAE96VNMU, 868001894EXKUNIVN09602Y2, 868001894EXKAE96VPMY, 868001894EXKMGVVR09602V4
- Direct Marketing DI
- 086800189404170868001894103208684198020976086800189419020868419802057008684198020082086841980205940868001894189608680018941759086800189465870868419802061708684198025155086800189461360868001894949608680018942954086841980205560868419802078508684198020549086800189463340868001894296108680018941353086800189426260868001894184108680018940721086841980206550868001894612908680018943180086800189431730868001894069108684198020839086841980205630868001894191908680018940660086841980206000868001894090508680018940851
- EMDN Code
- W0105900101, W0105040205, W02050106, W0105070501, W02050116, W0105070399, W0105070503
- Device Class
- Class AClass C
- EU market of registration
- TürkiyeItaly
Manufacturer details
- EUDAMED SRN
- TR-MF-000022487
Other devices from Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No