Clearblue
GUDID 00633472601323
CB6 Visual Pregnancy 2ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical| Primary Device ID | 00633472601323 |
| NIH Device Record Key | 2b2037cd-489f-47b6-8422-cfa0e217dcfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clearblue |
| Version Model Number | Reassurance Pregnancy Test with Color Change Tip |
| Company DUNS | 483609579 |
| Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx | |
| Phone | 1-800-321-3279 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00633472000027 [Unit of Use] |
| GS1 | 00633472601323 [Primary] |
| GS1 | 10633472601320 [Package] Package: Shipping case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040341
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-26 |
On-Brand Devices [Clearblue ]
| 10633472601542 | A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid Detecti |
| 10633472601344 | COTS Clearblue 25ct Ovulation + CB12 3ct Digital Pregnancy Bundle |
| 00633472601323 | CB6 Visual Pregnancy 2ct US |
| 10633472601207 | CBCOT Ovulation Advanced 25ct |
| 10633472601153 | A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 Cle |
| 10633472601146 | CB12 Pregnancy Digital- 1CT |
| 10633472601023 | A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid De |
| 10633472601894 | CBCOT Ovulation Advanced 40ct |
| 10633472601849 | CB11a Visual Pregnancy 1 Ct |
| 10633472600767 | CBDOT Clearblue Ovulation Digital 10ct Dual |
| 00633472600630 | CBHOT Visual Ovulation Stick 5 Ct |
| 00633472600708 | ADOT Clearblue Advanced Ovulation 20ct March of Dimes Dual US |
| 00633472600715 | ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US |
| 10633472600224 | Clearblue Fertility Monitor with touch screen 1ct US |
| 00633472022258 | Clearblue Fertility Monitor with touch screen fertility test sticks 30 ct |
| 10633472601719 | CB11a Visual Pregnancy 2 Ct |
| 10633472276894 | Clearblue Digital Ovulation Test 20ct dual |
| 10633472602051 | A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid |
| 10633472602099 | Clearblue Advanced Period Tracker 18ct |
| 10633472602198 | A convenience kit consisting of 25 Clearblue Digital Ovulation Tests and 2 Clearblue Rapid Dete |
| 10633472602181 | A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearblue Ra |
| 10633472602259 | Clearblue Preg Dig CB15 3ct US |
| 10633472602235 | CB Triple Conf Preg Test 3ct US |
| 10633472602297 | CB Preg Vis CB16 ED 5ct US |
| 10633472602280 | CB Preg Vis CB16 ED 3ct US |
| 10633472602273 | CB Preg Vis CB16 ED 2ct US |
| 10633472602266 | Clearblue Preg Dig CB15 2ct - US |
| 10633472602242 | CB Menopause Stage Indicator 5ct US |
| 10633472602365 | CB Preg Vis CB16 ED 1ct US |
| 10633472602341 | A convenience kit consisting of 1 Digital pregnancy test + 1 visual pregnancy test |
| 10633472602334 | A convenience kit consisting of 2 Digital pregnancy tests + 2 visual pregnancy tests |
| 10633472602327 | A convenience kit consisting of 2 Digital Pregnancy Tests + 8 Visual Pregnancy Tests |
| 10633472602310 | Clearblue Preg Dig CB15 5ct - US |
| 10633472602303 | Clearblue Preg Dig CB15 1ct - US |
Trademark Results [Clearblue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARBLUE 85941962 not registered Dead/Abandoned |
BBVA Compass Bancshares, Inc. 2013-05-24 |
 CLEARBLUE 78699151 3326587 Dead/Cancelled |
DAFCA, Inc. 2005-08-24 |
 CLEARBLUE 78231358 2924246 Live/Registered |
SPD SWISS PRECISION DIAGNOSTICS GMBH 2003-03-28 |
 CLEARBLUE 78231341 2958057 Live/Registered |
SPD Swiss Precision Diagnostics GmbH 2003-03-28 |
 CLEARBLUE 76262360 2715082 Dead/Cancelled |
AES Power Direct, L.L.D. 2001-05-24 |
 CLEARBLUE 76198958 not registered Dead/Abandoned |
C-POOL USA, LLC 2001-01-24 |
 CLEARBLUE 76055271 2629967 Dead/Cancelled |
CLEAR BLUE, INC. 2000-05-24 |
 CLEARBLUE 73633497 1492770 Live/Registered |
UNIPATH LIMITED 1986-12-03 |
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