25 Stk. Newgene COVID-19 Antigen Schnelltest – Nasal Swab – (Laientest)

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1 Test 5 Tests CE 1434 Laientest MHD 1er 07.2024 MHD 5 er 08.2024

Verpackungseinheit (VPE): 1 Test | 5 Tests
Mindestabnahme: 25 Tests

ACHTUNG: bitte beachten Sie dass das von Ihnen gewählte Produkt einer Einschränkung des Rückgaberechts nach § 312g Abs. 2 Nr. 3 BGB unterliegt. Da es sich bei dem Produkt um ein Medizinprodukt handelt, ist eine Rücknahme aus hygienischen Gründen ausgeschlossen.

Der COVID-19-Antigen Schnelltest ist ein Lateral-Flow-Immunoassay-Verfahren zum qualitativen Nachweis von SARS-CoV-2-Nukleokapsid-Antigenen im vorderen Nasenabstrich von Personen mit Verdacht auf eine COVID-19-Infektion und erkennt entsprechend der Stellungnahme vom 28.11.21 die Omikron Variante.

Mit der Änderung der EU-HSC (Gemeinsame-EU-Coronavirus-Testverordnung vom 26.07.2023) ist die Erstattungsfähigkeit der Antigen-Schnelltests neu geregelt und hier abrufbar.

BfArM gelistet AT1210/21
Evaluiert nach den Richtlinien des Paul-Ehrlich-Instituts
CE1434 zertifiziert
EU-RAT Liste: (ja)
PEI Liste-05.05.2022 (78%)
Nachweis mutierter Viren: BA.1, BA.2, BA.2.12.1, BA.2.75, BA.3, BA.4, BA.5, BF.7, BQ.1.1, XBB.
Vorgefüllte Pufferlösung
Sensitivität: 97,1%
Spezifität: 99,2%
Probenentnahme: Anterio Nasal Selbsttest – Abstrich im vorderen Nasenraum
Einfache Handhabung
Newgene COVID-19 Antigen Schnelltest – Testergebnis in nur 15 Minuten
Verwendbar bis:
– 26-07-2024 (1er)
– 18-08-2024 (5er)

Zusätzliche Information

Gewicht	n. a.
BfArM Zulassung: Bitte auswählen	Zulassung für Laien
Hersteller: Bitte auswählen	New Gene (Hangzhou) Bioengineering Co. Ltd.
Marke \| Label: Bitte auswählen	New Gene
Probenentnahme: Bitte auswählen	Vorderer Nasenbereich (Anterio-Nasaler Abstrich, 2,5 cm Tief)
Listung: Bitte auswählen	BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), PEI (Paul-Ehrlich-Institut)
VPE:: Bitte auswählen	25 Stk. 1er, 25 Stk. 5er

Zertifikate | Prüfberichte | Downloads

BfArM gelistet: Download
Konformitätserklärung: Download
NewGene Statement Mutationen: Download
Gebrauchsanweisung: Download

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25 Stk. Newgene COVID-19 Antigen Schnelltest – Nasal Swab – (Laientest)

ACHTUNG: bitte beachten Sie dass das von Ihnen gewählte Produkt einer Einschränkung des Rückgaberechts nach § 312g Abs. 2 Nr. 3 BGB unterliegt. Da es sich bei dem Produkt um ein Medizinprodukt handelt, ist eine Rücknahme aus hygienischen Gründen ausgeschlossen.

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25 Stk. Newgene COVID-19 Antigen Schnelltest – Nasal Swab – (Laientest)

ACHTUNG: bitte beachten Sie dass das von Ihnen gewählte Produkt einer Einschränkung des Rückgaberechts nach § 312g Abs. 2 Nr. 3 BGB unterliegt. Da es sich bei dem Produkt um ein Medizinprodukt handelt, ist eine Rücknahme aus hygienischen Gründen ausgeschlossen.

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