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

Premarket Exempt

No Yes

Clear

Clearblue - 00633472600425 Catalog Number :

Device Description : ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 10

Clearblue Advanced Digital Pregnancy Test with Weeks Estimator - 00633472600487 Catalog Number :

Device Description : CB9A Advanced Pregnancy Test with Weeks Estimator 2 CT

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Clearblue Advanced Digital Pregnancy Test with Weeks Estimator - 00633472600494 Catalog Number :

Device Description : CB9A Advanced Pregnancy Test with Weeks Estimator 3 CT

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 3

Clearblue Advanced Digital Pregnancy Test with Weeks Estimator - 00633472600562 Catalog Number :

Device Description : CB9A Advanced Pregnancy test with Weeks Estimator 1 CT

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472600630 Catalog Number :

Device Description : CBHOT Visual Ovulation Stick 5 Ct

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 5

Clearblue - 00633472600760 Catalog Number :

Device Description : CBDOT Clearblue Ovulation Digital 10ct Dual

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : NGE

Prescription Use : No

Device Count : 10

Clearblue - 00633472601026 Catalog Number :

Device Description : A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Cl A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid Dectection Pregnancy Test.

Device Class : 1

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX, CEP

Prescription Use : No

Device Count : 1

Clearblue - 00633472601149 Catalog Number :

Device Description : CB12 Pregnancy Digital- 1CT

Device Class : 2

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Clearblue - 00633472601156 Catalog Number :

Device Description : A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 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 - 00633472601200 Catalog Number :

Device Description : CBCOT Ovulation Advanced 25ct

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 25

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