OT80-Beurer Ovulation Predictor and Fertility Tracking Kit

GUDID 06938444982498

The product consist of 15 ovulation test strips, 15 FSH test strips and 2 pregnancy test strips.

Runbio Biotech Co., Ltd.

Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid 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 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 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 Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing

• Primary Device ID: 06938444982498
• NIH Device Record Key: d41bb913-699b-4e84-9cc0-b3fd37c19e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OT80-Beurer Ovulation Predictor and Fertility Tracking Kit
• Version Model Number: 82498
• Company DUNS: 545868502
• Company Name: Runbio Biotech Co., Ltd.
• 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: 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938444982498 [Primary]

FDA Product Code

• LHD: Device, Fertility Diagnostic, Proceptive

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: 2021-07-08
• Device Publish Date: 2021-06-30

Devices Manufactured by Runbio Biotech Co., Ltd.

• 06938444982641 - DAVID: 2022-07-25 DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crysta
• 06938444982603 - DAVID: 2022-07-11 DAVID Ovulation & Pregnancy Test is consisiting of 90 ovulation test strips and 30 pregnancy test strips .
• 06938444982610 - DAVID: 2022-07-11 DAVID Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in
• 00850014758431 - NATALIST PREGNANCY TEST STRIP 15 COUNT: 2022-02-04 NATALIST PREGNANCY TEST STRIP 15 COUNT is intended for the qualitative determination of human chorionic gonadotropin (hCG) in th
• 06938444982498 - OT80-Beurer Ovulation Predictor and Fertility Tracking Kit: 2021-07-08The product consist of 15 ovulation test strips, 15 FSH test strips and 2 pregnancy test strips.
• 06938444982498 - OT80-Beurer Ovulation Predictor and Fertility Tracking Kit: 2021-07-08 The product consist of 15 ovulation test strips, 15 FSH test strips and 2 pregnancy test strips.
• 06938444982481 - DAVID Ovulation Test Strip: 2021-06-09 DAVID Ovulation Test Strip is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizin
• 06938444982412 - DAVID: 2021-05-04 The convenience kit is consisiting of 30 ovulation test strips and 10 pregnancy test strips .
• 00850014758042 - NATALIST OVULATION TEST MIDSTREAM 10 COUNT: 2021-01-11 NATALIST OVULATION TEST MIDSTREAM 10 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of