Sentosa SA201 HSV-1/2 PCR Test 300216

GUDID 08885013953664

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.

VELA OPERATIONS SINGAPORE PTE. LTD.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

• Primary Device ID: 08885013953664
• NIH Device Record Key: 2d5c105b-d780-4747-8ef9-d6b83c532636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SA201 HSV-1/2 PCR Test
• Version Model Number: 300216
• Catalog Number: 300216
• Company DUNS: 595361724
• Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885013953664 [Primary]

FDA Product Code

• OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-07
• Device Publish Date: 2018-04-16

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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