Hema-Chek® Developer 2596
GUDID 00630414538396
For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood.
Siemens Healthcare Diagnostics Inc.
Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, chromogenic, rapid Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical Faecal occult blood IVD, kit, rapid colorimetric, clinical| Primary Device ID | 00630414538396 |
| NIH Device Record Key | b425a465-71fa-479f-adf0-e6e1abd50a8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hema-Chek® Developer |
| Version Model Number | 10313614 |
| Catalog Number | 2596 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 10 |
| 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 | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat, strong light and open flame. |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414009407 [Unit of Use] |
| GS1 | 00630414538396 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K830223
FDA Product Code
| KHE | REAGENT, OCCULT BLOOD |
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 |
Trademark Results [Hema-Chek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMA-CHEK 73357216 1262093 Live/Registered |
Miles Laboratories, Inc. 1982-03-29 |
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