Seegene STARlet 67930-03

GUDID 08809240109007

a liquid pipetting system for analytical and clinical use

SEEGENE, INC.

Pipetting system IVD
Primary Device ID08809240109007
NIH Device Record Key1d38089b-d3d5-4931-97ba-843b47cb9804
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeegene STARlet
Version Model Number1
Catalog Number67930-03
Company DUNS688370667
Company NameSEEGENE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108809240109007 [Primary]

FDA Product Code

JJHClinical Sample Concentrator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

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08809240109007 - Seegene STARlet2022-12-13a liquid pipetting system for analytical and clinical use
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