Clearblue
GUDID 10633472602297
CB Preg Vis CB16 ED 5ct US
SPD SWISS PRECISION DIAGNOSTICS GMBH
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 10633472602297 |
| NIH Device Record Key | 902fc88b-94aa-4a12-a125-3dfe406d92da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clearblue |
| Version Model Number | Early Detection Pregnancy Test |
| Company DUNS | 483609579 |
| Company Name | SPD SWISS PRECISION DIAGNOSTICS GMBH |
| Device Count | 5 |
| 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 | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 800 321 3279 |
| xx@xx.xx | |
| Phone | 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 |
| 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 | 00633472000584 [Unit of Use] |
| GS1 | 00633472602290 [Primary] |
| GS1 | 10633472602297 [Package] Contains: 00633472602290 Package: shipping case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213379
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-24 |
| Device Publish Date | 2023-05-16 |
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 |
| 00633472602412 | A convenience kit consisting of 15 Advanced Digital Ovulation tests + 1 Rapid Detection pregnanc |
| 00633472602405 | A convenience kit consisting of 30 Advanced Digital Ovulation tests + 2 Rapid Detection pregnanc |
| 00633472602399 | Clearblue Ovul Dig 30ct. US |
| 10633472602389 | CB Birth Control Refill 15ct US |
| 10633472602372 | A convenience kit consisting of 15 Digital Ovulation Tests, Digital Basal Thermometer and 3 mont |
| 10633472602488 | A convenience kit containing of 6 Early Tests and 1 Early Digital Test |
| 10633472602532 | CLEARBLUE OVUL DIG 40CT US |
Trademark Results [Clearblue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARBLUE 98808763 not registered Live/Pending |
SPD Swiss Precision Diagnostics GmbH 2024-10-18 |
 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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