UNIVERSAL MEDITECH INC.

Address:1320 E Fortune Ave,Fresno,CA,93725,US

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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

Kit, Test, Pregnancy, Hcg, Over The Counter (LCX) (2) Radioimmunoassay, Follicle-Stimulating Hormone (CGJ) (1) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (1)

Premarket Exempt

No Yes

Clear

DoublecheQ Pregnancy Test - 00860002273006 Catalog Number : 100-13

Device Description : The DoublecheQ Pregnancy Test is designed to be used for a qualitative determina The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in urine. The result can be read visually in minutes to indicate a positive or negative result for pregnancy.

Device Class : 2

Duns Number: 080243910

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

One Step Pregnancy Test - B512100011 Catalog Number : 100-01

Device Class : 2

Duns Number: 080243910

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

One Step Ovulation Test - B512200011 Catalog Number : 200-01

Device Class : 1

Duns Number: 080243910

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 1

One Step Menopausal Test - B512210011 Catalog Number : 210-01

Device Class : 1

Duns Number: 080243910

Premarket Exempt : Yes

Product Code : CGJ

Prescription Use : No

Device Count : 1

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