SPD SWISS PRECISION DIAGNOSTICS GMBH

Address:C O PROCTER & GAMBLE,PETIT LANCY, GENEVA Geneve,CH

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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) (8) Test, Luteinizing Hormone (Lh), Over The Counter (NGE) (3) Radioimmunoassay, Luteinizing Hormone (CEP) (2)

Premarket Exempt

No Yes

Clear

Clearblue - 00633472601323 Catalog Number :

Device Description : CB6 Visual Pregnancy 2ct US

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Clearblue - 00633472601347 Catalog Number :

Device Description : COTS Clearblue 25ct Ovulation + CB12 3ct Digital Pregnancy Bundle

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX, CEP

Prescription Use : No

Device Count : 28

Clearblue - 00633472601545 Catalog Number :

Device Description : A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearbl A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid Detection Pregnancy Test devices

Device Class : 2

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472601712 Catalog Number :

Device Description : CB11a Visual Pregnancy 2 Ct

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Clearblue - 00633472601842 Catalog Number :

Device Description : CB11a Visual Pregnancy 1 Ct

Device Class : 2

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472601897 Catalog Number :

Device Description : CBCOT Ovulation Advanced 40ct

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 40

Clearblue - 00633472602054 Catalog Number :

Device Description : A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid Detection Pregnancy Test devices

Device Class : 2

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472602092 Catalog Number :

Device Description : Clearblue Advanced Period Tracker 18ct

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 18

Clearblue - 00633472602184 Catalog Number :

Device Description : A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests an A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearblue Rapid Detection Pregnancy Tests

Device Class : 1

Duns Number: 483609579

Premarket Exempt : No

Product Code : NGE, LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472602191 Catalog Number :

Device Description : A convenience kit consisting of 25 Clearblue Digital Ovulation Tests and 2 Clea A convenience kit consisting of 25 Clearblue Digital Ovulation Tests and 2 Clearblue Rapid Detection Pregnancy Tests

Device Class : 1

Duns Number: 483609579

Premarket Exempt : No

Product Code : NGE, LCX

Prescription Use : No

Device Count : 1

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