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) (10)

Premarket Exempt

No Yes

Clear

Family Wellness Early Result Pregnancy Test - 00032251060748 Catalog Number :

Device Description : Family Wellness Early Result Pregnancy Test

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Family Wellness Early Result Pregnancy Test - 00032251064494 Catalog Number :

Device Description : Family Wellness Early Result Pregnancy Test

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Equaline One Step Pregnancy Test - 00041163250932 Catalog Number :

Device Description : FPPL Equaline SPS +/- (ER)

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Equaline One Step Pregnancy Test - 00041163250949 Catalog Number :

Device Description : FPPL Equaline DPS +/- (ER)

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Equaline Digital Pregnancy Test - 00041163458291 Catalog Number :

Device Description : CB8 Digital Pregnancy Stick Equaline DPS Digital Early (ER) US

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Equaline Early Result Pregnancy Test - 00041163458307 Catalog Number :

Device Description : Equaline DPS Early Result

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Equaline - 00041163502963 Catalog Number :

Device Description : Equaline SPS Early Result

Device Class : 2

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

Equaline - 00041163502970 Catalog Number :

Device Description : EQUALINE DPS +/- Blue Cap

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Equaline - 00041163502987 Catalog Number :

Device Description : Equaline DPS Digital Early Blue

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 2

Shopko - 00400028325824 Catalog Number :

Device Description : FPPL Shopko SPS +/-

Device Class :

Duns Number: 483609579

Premarket Exempt : No

Product Code : LCX

Prescription Use : No

Device Count : 1

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