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) (9) Radioimmunoassay, Luteinizing Hormone (CEP) (1)

Premarket Exempt

No Yes

Clear

Shopko - 00400080776756 Catalog Number :

Device Description : Shopko DPS Early Result

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Shopko - 00400103056704 Catalog Number :

Device Description : FPPL Shopko DPS +/-

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Shopko - 00400160638936 Catalog Number :

Device Description : Shopko DPS Early Bilingual

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Exchange Select One Step Pregnancy Test - 00614299396418 Catalog Number :

Device Description : Exchange Select SPS

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Exchange Select One Step Pregnancy Test - 00614299396425 Catalog Number :

Device Description : FPPL Exchange Select DPS +/- (ER)

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Exchange Select - 00614299396432 Catalog Number :

Device Description : Exchange Select One Step Ovulation Predictor

Device Class :

Duns Number: 483609579

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 7

Exchange Select Early Result Pregnancy Test - 00614299402676 Catalog Number :

Device Description : PLPL Exchange Select DPS Early Result

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Exchange Select - 00614299437388 Catalog Number :

Device Description : Exchange Select DPS +/-Blue Cap

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Clearblue Pregnancy Test with Smart Countdown - 00633472002908 Catalog Number :

Device Description : CB12 Pregnancy Digital 2 CT

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Clearblue Pregnancy Test with Smart Countdown - 00633472002953 Catalog Number :

Device Description : CB12 Digital Pregnancy 3 CT Dual

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 3

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