PreKnow

GUDID 00857275007445

LH Ovulation Test Strip-3.5mm

IDUN SOLUTIONS LLC

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00857275007445
• NIH Device Record Key: 473b649f-60ad-4e9f-a26b-756b1969183a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: 21103015410508
• Company DUNS: 080651010
• Company Name: IDUN SOLUTIONS LLC
• 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: false
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857275007445 [Package]; Contains: 00857275007551; Package: [100 Units]; In Commercial Distribution
GS1	00857275007551 [Primary]

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

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: 2018-09-03
• Device Publish Date: 2018-08-02

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