STARMag 96 X 4 Viral DNA/RNA 200 C Kit EX00013C

GUDID 08809240000137

for isolation of nucleic acid from nasopharyngeal swab, urine, stool and genital swabs (vaginal, cervical, urethral) using automated liquid handling instrument

SEEGENE, INC.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08809240000137
• NIH Device Record Key: 8a822e41-768b-4c74-a41d-a6f771c1132e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARMag 96 X 4 Viral DNA/RNA 200 C Kit
• Version Model Number: 1
• Catalog Number: EX00013C
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809240000137 [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: 2022-12-13
• Device Publish Date: 2022-12-05

Devices Manufactured by SEEGENE, INC.

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• 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
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