Runbio Biotech Co., Ltd.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Urine Collection Kit (Excludes Hiv Testing) (OIE) (8) Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (1) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (1)

Premarket Exempt

No Yes

Clear

DAVID Ovulation Test Midstream - 06938444980074 Catalog Number : RH-LH-B

Device Description : The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoa The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.

Device Class :

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 10

DAVID OVULATION TEST KIT - 06938444980128 Catalog Number :

Device Description : The convenience kit consisting of 50 Ovulation Test device and 25 Pregnancy Test devices.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

Emay - 06938444980173 Catalog Number : 1

Device Description : The convenience kit consisting of 60 Ovulation Test device and 20 Pregnancy Test devices.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

Smilereader ovulation test kit - 06938444981002 Catalog Number :

Device Description : The convenience kit consisting of 5 Ovulation Test device and 1 Pregnancy Test devices.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

Smilereader ovulation test kit - 06938444981019 Catalog Number :

Device Description : The convenience kit consisting of 15 ovulation test devices and 5 pregnancy test devices.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

Smilereader Ovulation test kit(30LH+10HCG) - 06938444981026 Catalog Number :

Device Description : The convenience kit consisiting of 30 Ovulation Test device and 10 Pregnancy Test devices.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : No

Product Code : OIE

Prescription Use : No

Device Count : 1

DrKea+ - 06938444981309 Catalog Number :

Device Description : The convenience kit consisiting of 50 ovulation test strips 4mm and 20 pregnancy The convenience kit consisiting of 50 ovulation test strips 4mm and 20 pregnancy test strips 4mm.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

INVBIO - 06938444981316 Catalog Number :

Device Description : HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitat HCG Pregnancy Test Strip is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. It is for over-the-counter use. It consists of 25 strips.

Device Class : 2

Duns Number: 545868502

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

INVBIO - 06938444981323 Catalog Number :

Device Description : The convenience kit consisiting of 50 ovulation test strips 3mm and 20 pregnancy The convenience kit consisiting of 50 ovulation test strips 3mm and 20 pregnancy test strips 3mm.

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

Early Blush Ovulation Test Kit - 06938444982177 Catalog Number :

Device Description : The convenience kit is consisiting of 40 ovulation test strips and 15 pregnancy The convenience kit is consisiting of 40 ovulation test strips and 15 pregnancy test strips .

Device Class : 1

Duns Number: 545868502

Premarket Exempt : Yes

Product Code : OIE

Prescription Use : No

Device Count : 1

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