EURORealTime SARS-CoV-2

GUDID 04049016145653

EUROIMMUN Medizinische Labordiagnostika AG

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID04049016145653
NIH Device Record Key6dd32380-7005-4b53-8f39-2e1c2a791313
Commercial Distribution StatusIn Commercial Distribution
Brand NameEURORealTime SARS-CoV-2
Version Model NumberMP 2606-0225
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016145653 [Primary]

FDA Product Code

QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-12
Device Publish Date2020-08-04

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

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

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