FDA Registration
Active
🇨🇭 Switzerland
SPD SWISS PRECISION DIAGNOSTICS GMBH
Reg #: 3006635320
·
FEI: 3006635320
·
Expires 2026
Products
3
Proprietary Names
117
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- SPD SWISS PRECISION DIAGNOSTICS GMBH
- Registration Number
- 3006635320
- FEI Number
- 3006635320
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- C O PROCTER & GAMBLE, 47 ROUTE DE SAINT GEORGES
- City
- PETIT LANCY, GENEVA Geneve
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K981271
Owner / Operator
- Firm Name
- SPD SWISS PRECISION DIAGNOSTICS GMBH
- Operator Number
- 9102922
- Address
- C/O PROCTER & GAMBLE, 47 ROUTE DE SAINT-GEORGES
- City
- PETIT-LANCY, GENEVA
- State
- CH-NOTA
- Postal Code
- CH-1213
- Country
- CH
- Correspondent
- Cameron Houston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2010-01-08 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2007-06-13 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2016-07-19 |
Proprietary Names
Clearblue Trying for a Baby Ovulation Kit
Clearblue & Natural Cycles° Birth Control Kit Starter Pack
Clearblue Advanced Digital Ovulation Test Kit
Clearblue Trying for a Baby Advanced Ovulation Kit
Clearblue Digital Ovulation Test
Clearblue Smart Ovulation Test
Clearblue Advanced Digital Ovulation Test
Clearblue Period Cycle Tracker
Clearblue Easy Ovulation Kit
CVS Early Ovulation Test Kit
TOPCARE HEALTH EARLY OVULATION TEST
HEB EARLY OVULATION KIT TEST
UP&UP EARLY OVULATION TEST
EQUATE EARLY OVULATION TEST
KROGER EARLY OVULATION TEST
MEIJER CLEAR ANSWER EARLY OVULATION TEST
Clearblue Digital Prueba de Embarazo
Clearblue Advanced Digital Pregnancy Test
Clearblue Early Detection Pregnancy Test
Clearblue Digital & Rapid Detection Pregnancy Test
Clearblue Advanced Fertility Monitor
Clearblue Advanced Fertility Monitor Pregnancy Test Sticks
Clearblue Pregnancy Test Digital Ultra Early
Clearblue Rapid Detection Pregnancy Test
Clearblue Flip & Click Pregnancy Test
Clearblue Rapid & Digital Pregnancy Tests
Clearblue Triple Assurance Pregnancy Tests
Dollar General One Step Pregnancy Test
CVP Health One Step Pregnancy Test
CVS Health One Step Pregnancy Test
CareOne One Step Pregnancy Test
Equate One Step Pregnancy Test
Signature Care One Step Pregnancy Test
Equaline One Step Pregnancy Test
TopCare Health One Step Pregnancy Test
Walgreens One Step Pregnancy Test
Clearblue Fertility Monitor Test Sticks
Clearblue Fertility Monitor with Touch Screen
CareOne Digital Wide-Tip Pregnancy Test
Clearblue Digital Pregnancy Test
HEB Digital Wide-Tip Pregnancy Test
Kroger Digital Wide-Tip Pregnancy Test
CVS HEALTH DIGITAL & ONE STEP PREGNANCY TEST KIT
Signature Care Digital Pregnancy Test
EQUATE DIGITAL PREGNANCY TEST
CVS Health Digital & Early Result Pregnancy Test Kit
Kroger Digital Pregnancy Test
WALGREENS DIGITAL & EARLY RESULT PREGNANCY TESTS
MEIJER CLEAR ANSWER DIGITAL PREGNANCY TEST
MEIJER DIGITAL & EARLY RESULT PREGNANCY TEST
CVS Health Digital Wide-Tip Pregnancy Test
Amazon Digital Wide-Tip Pregnancy Test
KROGER DIGITAL & ONE STEP PREGNANCY TEST
Amazon Digital Pregnancy Test
Equaline Digital Wide-Tip Pregnancy Test
CVS HEALTH DIGITAL PREGNANCY TEST
Signature Care Digital Wide-Tip Pregnancy Test
TopCare Health Digital Wide-Tip Pregnancy Test
Walgreens Digital Pregnancy Test
TOPCARE HEALTH ONE STEP PREGNANCY TEST
SIGNATURE CARE EARLY RESULT PREGNANCY TEST
CVS HEALTH BILINGUAL EARLY RESULT PREGNANCY TEST
EQUATE TRIPLE TEST PREGNANCY TEST KIT
7SELECT EARLY RESULT PREGNANCY TEST
CVS HEALTH ADVANCED ONE STEP PREGNANCY TEST
CAREONE EARLY RESULT PREGNANCY TEST
ACCU-CLEAR PREGANCY TEST
UP&UP ADVANCED EARLY RESULT PREGNANCY TEST
SIGNATURE CARE ONE STEP PREGNANCY TEST
MEIJER ADVANCED EARLY RESULT PREGNANCY TEST
CVS HEALTH DIGITAL WIDE-TIP & ADVANCED ONE STEP PREGNANCY TESTS
FIRST SIGNAL EARLY RESULT PREGNANCY TEST
KROGER ADVANCED EARLY RESULT PREGNANCY TEST
EQUALINE EARLY RESULT PREGNANCY TEST
MEIJER CLEAR ANSWER ADVANCED ONE STEP PREGNANCY TEST
WALGREENS TRIPLE TEST PREGNANCY TEST KIT
KROGER ADVANCED ONE STEP +/- PREGNANCY TEST
TOPCARE HEALTH EARLY RESULT PREGNANCY TEST
DG Health One Step Pregnancy Test
CVS HEALTH ONE STEP PREGNANCY TEST
CVS TRIPLE TEST PREGNANCY TEST KIT
Meijer Digital Wide-Tip & Early Result Pregnancy Tests
EQUALINE ONE STEP PREGNANCY TEST
Kroger Digital Wide-Tip & One Step Pregnancy Tests
HEB ADVANCED ONE STEP PREGANCY TEST
CAREONE ONE STEP PREGNANCY TEST
Walgreens Digital & One Step Pregnancy Tests
HEB ADVANCED EARLY RESULT PREGNANCY TEST
WALGREENS EARLY RESULT PREGNANCY TEST
WALGREENS ONE STEP PREGNANCY TEST
HEB Digital Wide-Tip & Early Result Pregnancy Tests
MEIJER CLEAR ANSWER ONE STEP PREGNANCY TEST
AMAZON EARLY RESULT PREGNANCY TEST
WALGREENS ADVANCED EARLY RESULT PREGNANCY TEST
EQUATE ONE STEP PREGNANCY TEST
CVS HEALTH DIGITAL WIDE-TIP & ADVANCED EARLY RESULT PREGNANCY TESTS
MEIJER EARLY RESULT PREGNANCY TEST
Rexall One Step Pregnancy Test
CVS HEALTH EARLY RESULT PREGNANCY TEST
WALGREENS ADVANCED ONE STEP PREGNANCY TEST
Equate Advanced Early Result Pregnancy Test
EXCHANGE SELECT ONE STEP PREGNANCY TEST
FIRST SIGNAL ONE STEP PREGNANCY TEST
H.E.B One-Step Cassette Pregnancy Test
Clearblue Early Digital Pregnancy Test
Clearblue Early & Digital Pregnancy Tests
Clearblue Early Combo Pack Pregnancy Tests
Clearblue Early Assurance Combo Pregnancy Tests
HEB 6 Days Sooner Pregnancy Test
Walgreens 6 Days Sooner Pregnancy Test
Meijer 6 Days Sooner Pregnancy Test
DG Health 6 Days Sooner Pregnancy Test
Amazon 6 Days Sooner Pregnancy Test
Clearblue Bilingual Early Detection Pregnancy Test
UP & UP Early Visual & Early Digital Pregnancy Tests
UP & UP 6 Days Sooner Pregnancy Test
CVS Health 6 Days Sooner Pregnancy Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device