Pregcolor Premium

GUDID 00695684971014

GERMAINE LABORATORIES, INC

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 00695684971014
• NIH Device Record Key: 8a7823ef-ba18-4c9c-a47f-750234a132b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregcolor Premium
• Version Model Number: 97101PCP
• Company DUNS: 176458115
• Company Name: GERMAINE LABORATORIES, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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	00695684971014 [Primary]

FDA Product Code

• DHA: System, Test, Human Chorionic Gonadotropin

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: 2023-08-17
• Device Publish Date: 2023-08-09

Devices Manufactured by GERMAINE LABORATORIES, INC

• 10695684423381 - AimScreen Fentanyl: 2024-04-09
• 00695684893019 - Pregcolor Plus: 2023-08-17
• 00695684971014 - Pregcolor Premium: 2023-08-17
• 00695684971014 - Pregcolor Premium: 2023-08-17
• 00695684410117 - SAFECUP III MULTIDRUG 11: 2022-08-25 Rapid qualitative tests for the detection of drugs of abuse in urine. All-in-One Cup, tests for AMP, BAR, BZO, BUP, COC, MTD, MD
• 00695684444310 - SAFECUP III 13 PANEL: 2022-08-25
• 00695684754075 - Mosie Baby Ovulation Test: 2020-01-31 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel
• 00695684957018 - Mosie Baby Pregnancy Test: 2020-01-31 Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results withi
• 06956847540756 - Mosie Baby Ovulation Test: 2019-10-29 Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for sel