ACCUHOME OVULATION

GUDID 00695684755409

Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for self testing (home).

GERMAINE LABORATORIES, INC

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

• Primary Device ID: 00695684755409
• NIH Device Record Key: 251bb233-c6d1-4cbe-b2f1-a2c63d9eadfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUHOME OVULATION
• Version Model Number: 75540
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 40
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00695684755401 [Unit of Use]
GS1	00695684755409 [Primary]

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-27

On-Brand Devices [ACCUHOME OVULATION]

• 00695684755409: Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the
• 00695684755010: Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the