DEVICE: Sentosa SA201 HSV-1/2 PCR Test (08885013953664)

Device Identifier (DI) Information

Sentosa SA201 HSV-1/2 PCR Test
300216
In Commercial Distribution
300216
VELA OPERATIONS SINGAPORE PTE. LTD.
08885013953664
GS1

1
595361724 *Terms of Use
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48033 Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
An electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d5c105b-d780-4747-8ef9-d6b83c532636
July 07, 2020
2
April 16, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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