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ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96)

FDA UDIEUDAMED

by Vela Operations Singapore Pte. Ltd.

Identity

Trade Name
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) FDA UDI
Generic Name
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage samples collected from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. FDA UDI
Model / Reference
301085 FDA UDI
Description
ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal or nasopharyngeal aspirates, nasal washes and bronchoalveolar lavage samples collected from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. FDA UDI

Identifiers

Primary DI / UDI-DI
08885013953855 FDA UDI
GMDN Term
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) by Vela Operations Singapore Pte. Ltd. — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vela Operations Singapore Pte. Ltd.

Sources (2)

  • FDA UDI 4f4a5967-4231-443c-b9fa-dd356aff028c 33 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026