QuPID® Plus Sample Pack 1230-003
GUDID 00657498002056
For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.
STANBIO LABORATORY, L.P.
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 | 00657498002056 |
| NIH Device Record Key | 635f60c7-1871-48ab-9c46-225520fec776 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuPID® Plus Sample Pack |
| Version Model Number | 1230-003 |
| Catalog Number | 1230-003 |
| Company DUNS | 045361136 |
| Company Name | STANBIO LABORATORY, L.P. |
| Device Count | 3 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.com | |
| Phone | 18005315535 |
| stanbiolab@ekfdiagnostics.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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00657498002049 [Unit of Use] |
| GS1 | 00657498002056 [Primary] |
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-15 |
| Device Publish Date | 2018-05-15 |
Devices Manufactured by STANBIO LABORATORY, L.P.
| 00657498002094 - Uri-Trak 120 M Urine Analyzer | 2023-06-16 The Uri-Trak® 120 M Urine Analyzer is intended for use in conjunction with the Uri-Chek® 10SG Urinalysis Reagent Strips for th |
| 00657498002322 - HGB Controls - Low | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002339 - HGB Controls - Low | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002346 - HGB Controls - Normal | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002353 - HGB Controls - Normal | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002360 - HGB Controls - High | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498002377 - HGB Controls - High | 2021-04-08 A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. |
| 00657498001806 - Standard 1 | 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy |
Trademark Results [QuPID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUPID 76416923 2801129 Live/Registered |
East Lion Corporation 2002-06-03 |
 QUPID 76167660 2506475 Live/Registered |
STANBIO LABORATORY 2000-11-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.