OC-Auto
GUDID 00816917026190
OC-Auto SENSOR io Personal Use Kit for Sharp Healthcare Laboratory
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent Faecal occult blood IVD, reagent| Primary Device ID | 00816917026190 |
| NIH Device Record Key | 16712690-4b7a-42c0-908d-48446abdcbbf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OC-Auto |
| Version Model Number | OCPUIO-SHCP |
| Company DUNS | 078413594 |
| Company Name | POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816917026190 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191147
FDA Product Code
| OOX | Automated Occult Blood Analyzer |
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 | 2023-12-08 |
| Device Publish Date | 2023-11-30 |
On-Brand Devices [OC-Auto]
| 00816917024547 | Personal Use Kit OC-Auto, for Yale New Haven Medical |
| 00816917024530 | Personal Use Kit OC-Auto, for Bronson Methodist Hospital Lab |
| 00816917024523 | Personal Use Kit OC-Auto, for Middletown Medical |
| 00816917024516 | Personal Use Kit OC-Auto, no mailer, for customers |
| 00816917024486 | Personal Use Kit OC-Auto, for UPHT |
| 00816917024479 | Personal Use Kit OC-Auto, for LASF |
| 00816917024462 | Personal Use Kit OC-Auto, for LAGL |
| 00816917024455 | Personal Use Kit OC-Auto, for LAMV |
| 00816917024448 | Personal Use Kit OC-Auto, for Huntington Int Med Gro |
| 00816917024424 | Personal Use Kit OC-Auto, for MCHC |
| 00816917024417 | Personal Use Kit OC-Auto, for SLHP |
| 00816917024400 | Personal Use Kit OC-Auto, Custom Kit for Virginia Physicians |
| 00816917024394 | Personal Use Kit OC-Auto, for Valley Care Hlth Sys |
| 00816917024387 | Personal Use Kit OC-Auto, Custom Kit for UNC |
| 00816917024370 | Personal Use Kit OC-Auto, for Univ of MO |
| 00816917024363 | Personal Use Kit OC-Auto, Custom Kit for Umass Memorial Hospital Med Center |
| 00816917024356 | Personal Use Kit OC-Auto, Custom Kit for UM4 |
| 00816917024349 | Personal Use Kit OC-Auto, for Univ of Miami |
| 00816917024332 | Personal Use Kit OC-Auto, Custom Kit for The Longstreet Clin |
| 00816917024325 | Personal Use Kit OC-Auto, Custom Kit for St Cloud Medical |
| 00816917024318 | Personal Use Kit OC-Auto, for Rockford Memorial Hosp |
| 00816917024301 | Personal Use Kit OC-Auto, for Rancho Los Amigos |
| 00816917024295 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab GEM |
| 00816917024288 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH7 |
| 00816917024271 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH6 |
| 00816917024264 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH5 |
| 00816917024257 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH4 |
| 00816917024240 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH3 |
| 00816917024233 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH2 |
| 00816917024226 | Personal Use Kit OC-Auto, Custom Kit for Phy A Lab AH1 |
| 00816917024219 | Personal Use Kit OC-Auto, for Prevea Health East |
| 00816917024202 | Personal Use Kit OC-Auto, Custom Kit for Path Group |
| 00816917024196 | Personal Use Kit OC-Auto, for Mem Med Center |
| 00816917024189 | Personal Use Kit OC-Auto, for MedLabs |
| 00816917024172 | Personal Use Kit OC-Auto, for McLaren Med Ctr-Macomb |
| 00816917024165 | Personal Use Kit OC-Auto, for McLaren Oakland |
| 00816917024158 | Personal Use Kit OC-Auto, for McLaren Flint Med Labs |
| 00816917024141 | Personal Use Kit OC-Auto, for Monroe Clinic |
| 00816917024134 | Personal Use Kit OC-Auto, Custom Kit for Lovelace Health Plan |
| 00816917024127 | Personal Use Kit OC-Auto, Custom Kit for W.T Evjue Clin |
| 00816917024110 | Personal Use Kit OC-Auto, Custom Kit for Jyc & Mrsh E Clin |
| 00816917024103 | Personal Use Kit OC-Auto, Custom Kit for LAC Itasca, IL |
| 00816917024097 | Personal Use Kit OC-Auto, Custom Kit for LAC Roybal |
| 00816917024080 | Personal Use Kit OC-Auto, Custom Kit for LAC El Monte |
| 00816917024073 | Personal Use Kit OC-Auto, Custom Kit for Jefferson Medical Center |
| 00816917024066 | Personal Use Kit OC-Auto, for Jackson Madison CtyGenHos |
| 00816917024059 | Personal Use Kit OC-Auto, for Jackson Clinic |
| 00816917024042 | Personal Use Kit OC-Auto, Custom Kit for HI West Mgmt Grp |
| 00816917024035 | Personal Use Kit OC-Auto, for Gunderson Hlth System |
| 00816917024028 | Personal Use Kit OC-Auto, for Dynacare Lab |
Trademark Results [OC-Auto]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OC-AUTO 76597320 3022594 Live/Registered |
Eiken Kagaku Kabushiki Kaisha 2004-06-15 |
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