CLINITEST® hCG Pregnancy Test 1760
GUDID 00630414473604
For in vitro diagnostics use in the detection of human chorionic gonadotropin (hCG) in urine using the Clinitek Status® analyzer(qualitative)
Siemens Healthcare Diagnostics Inc.
Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical| Primary Device ID | 00630414473604 |
| NIH Device Record Key | e64beb9c-7183-4d76-8bcd-070662837ec4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLINITEST® hCG Pregnancy Test |
| Version Model Number | 10310618 |
| Catalog Number | 1760 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 1 |
| 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 | false |
Customer Support Contacts
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
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 |
| 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 | 00630414473604 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032563
FDA Product Code
| JHI | Visual, pregnancy hCG, prescription use |
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 | 2016-09-24 |
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| 00630414317427 - Clinistix UTI Test Strips | 2024-02-29 Test strips for urinary tract infection |
| 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ADVIA Centaur - MCM Set |
| 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
| 00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
| 00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
| 00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
Trademark Results [CLINITEST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLINITEST 90976382 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2020-09-30 |
 CLINITEST 90225079 not registered Live/Pending |
Siemens Healthcare Diagnostics Inc. 2020-09-30 |
 CLINITEST 87704620 5636199 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2017-12-01 |
 CLINITEST 71578068 0542318 Dead/Expired |
AMES COMPANY, INC. 1949-05-02 |
 CLINITEST 71544685 0502711 Live/Registered |
AMES COMPANY, INC. 1947-12-18 |
 CLINITEST 71444567 0391675 Dead/Cancelled |
Effervescent Products, Inc. 1941-06-16 |
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