STARMag M96 Kit EX00029P

GUDID 08809240000281

for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, fecal swab, semen, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), whole blood and cerebrospinal fluid (CSF) specimen using automated liquid handling instrument

SEEGENE, INC.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08809240000281
• NIH Device Record Key: ae70e94e-2ab5-45e9-8d12-805a48f6cf09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARMag M96 Kit
• Version Model Number: 1
• Catalog Number: EX00029P
• Company DUNS: 688370667
• Company Name: SEEGENE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809240000281 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2024-07-08
• Device Publish Date: 2024-06-28

Devices Manufactured by SEEGENE, INC.

• 08809240000281 - STARMag M96 Kit: 2024-07-08for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, fecal swab, semen, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), whole blood and cerebrospinal fluid (CSF) specimen using automated liquid handling instrument
• 08809240000281 - STARMag M96 Kit: 2024-07-08 for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, f
• 08809240000007 - STARMag 96x4 Universal Cartridge Kit: 2022-12-13 for isolation of nucleic acid from tissue, cells, bacteria, serum, plasma, nasopharyngeal swab, nasopharyngeal aspirates, bronch
• 08809240000069 - STARMag 96x4 Universal Plus Cartridge Kit: 2022-12-13 for isolation of nucleic acid from serum, plasma, and whole blood specimen using automated liquid handling instrument
• 08809240000137 - STARMag 96 X 4 Viral DNA/RNA 200 C Kit: 2022-12-13 for isolation of nucleic acid from nasopharyngeal swab, urine, stool and genital swabs (vaginal, cervical, urethral) using autom
• 08809240109007 - Seegene STARlet: 2022-12-13 a liquid pipetting system for analytical and clinical use
• 08809240109014 - Seegene NIMBUS: 2022-12-13 a liquid pipetting system for analytical and clinical use