EURORealTime SARS-CoV-2

GUDID 04049016145646

EUROIMMUN Medizinische Labordiagnostika AG

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

• Primary Device ID: 04049016145646
• NIH Device Record Key: 5dfda19e-651e-46cb-9b62-d8a0926ac905
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EURORealTime SARS-CoV-2
• Version Model Number: MP 2606-0125
• Company DUNS: 322209263
• Company Name: EUROIMMUN Medizinische Labordiagnostika AG
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049016145646 [Primary]

FDA Product Code

• QJR: Reagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-12
• Device Publish Date: 2020-08-04

On-Brand Devices [EURORealTime SARS-CoV-2]

• 04049016145745: MP 2606-0200
• 04049016145691: MP 2606-0100
• 04049016145660: MP 2606-0425
• 04049016145653: MP 2606-0225
• 04049016145646: MP 2606-0125