OC-Auto
The OC-Auto Personal Use Kit is a stool-sample collection kit used with Polymedco’s OC-Auto fecal occult blood testing system. It provides a sampling bottle and collection materials so a…
The OC-Auto Personal Use Kit is a stool-sample collection kit used with Polymedco’s OC-Auto fecal occult blood testing system. It provides a sampling bottle and collection materials so a specimen can be collected and returned to a clinic or laboratory for analysis.
The listed model OCPU-UCHM is an accessory kit associated with the OC-Auto testing workflow. The kit collects and holds the specimen; the analyzer and test reagents perform the laboratory measurement.
Listed Item
Personal Use Kit OC-Auto, for University of Colorado Health Memorial Hospital Central
Kit Components
Manufacturer instructions list collection paper, a sampling bottle with probe and return materials for the personal-use kit.
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
Record
| Listed by | Polymedco Cancer Diagnostic Products LLC |
|---|---|
| FDA product code | OOX |
| Device type | Automated Occult Blood Analyzer |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| 510(k) | K041408 |
| Record published | 2020-10-01 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 2 to 30 °C |
| Distribution end date | 2019-02-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCPU-VA1 918168 | In distribution | |
| OCPUIO-VA1 5000069 | In distribution | |
| OCPU-JMCGH | In distribution | |
| OCPU-VA1 2334383 | In distribution | |
| OCPU-NEGD | In distribution | |
| OCPU-SHE | In distribution | |
| OCPU-LBCP SEWA | In distribution | |
| OCPU-UCHM | In distribution | |
| OCPU-SMDC | In distribution | |
| OCPU-LDL | In distribution | |
| OCPUIO-VA1 2333543 | In distribution | |
| OCPU-VA1 2334512 | In distribution | |
| OCPUIO-VA1 2334346 | In distribution | |
| OCPU-UC | In distribution | |
| OCPU-VA1 2334369 | In distribution | |
| OCPU-KPS FT | In distribution | |
| OCPU-MPMG | In distribution | |
| OCPU-VA1 2333651 | In distribution | |
| OCPU-BH | In distribution | |
| OCPUIO-UC | In distribution | |
| OCPU-DYNA | In distribution | |
| OCPU-KPD | In distribution | |
| OCPUIO-SWMH | In distribution | |
| OCPU-MHAM | In distribution | |
| OCPUIO-NEMS | In distribution | |
| OCPU-BL | In distribution | |
| OCPUIO-VA1 2334394 | In distribution | |
| OCPU-SCR | In distribution | |
| OCPU-KPMA | In distribution | |
| OCPUIO-VA1 2334485 | In distribution | |
| OCPU-VA1 213240 | In distribution | |
| OCPUIO-VA1 2333981 | In distribution | |
| OCPUIO-PCH | In distribution | |
| OCS2BRZL | In distribution | |
| OCPU-VA1 916076 | In distribution | |
| OCPU-EBMF | In distribution | |
| OCS1BRZL | In distribution | |
| OCPU-LBCP EVIL | In distribution | |
| OCPU-UCSF | In distribution | |
| OCPU-VA1 2334399 | In distribution | |
| OCPUIO-VA1 916985 | In distribution | |
| OCPU-CUSTOM | In distribution | |
| OCPU-IHC2 | In distribution | |
| OCPUIO-VA1 213246 | In distribution | |
| OCPU | In distribution | |
| OCPU-VA1 2334325 | In distribution | |
| OCPU-VA1 918082 | In distribution | |
| OCPU-SCL2 | In distribution | |
| OCPU-KPS PC | In distribution | |
| OCPU-VA1 2334516 | In distribution | |
| OCPU-VA1 2334337 | In distribution | |
| OCPU-VA1 2333536 | In distribution | |
| OCPU-FPP | In distribution | |
| OCPU-SLHP | In distribution | |
| OCPU-BCH | In distribution | |
| OCPUIO-VA1 2333556 | In distribution | |
| OCPU-VA1 2334381 | In distribution | |
| OCPU-SCL | In distribution | |
| OC80 | In distribution | |
| OCPU-MCMP | In distribution | |
| OCPU-THNH | In distribution | |
| OCPU-CCTX | In distribution | |
| OCPU-PL | In distribution | |
| OCPU-FCNL | In distribution | |
| OCPUIO-VA1 213247 | In distribution | |
| OCPU-CFHL | In distribution | |
| OCPU-ASP-PD | In distribution | |
| OCPUIO-DHMR | In distribution | |
| OCPUIO-SHE | In distribution | |
| OCPUIO-AULT | In distribution | |
| OCPU-R-U | In distribution | |
| OCPU-PAML | In distribution | |
| OCPU-UAB | In distribution | |
| OCDW | In distribution | |
| OCPU-LAC WTEC | In distribution | |
| OCPU-MAYOML | In distribution | |
| OCPU-MEMHS | In distribution | |
| OCPU-MLH | In distribution | |
| OCPU-GHMC | In distribution | |
| OCPUIO-DLS | In distribution | |
| OCPUIO-CFHL | In distribution | |
| OCPUIO-VA1 915894 | In distribution | |
| OCPU-VA1 916099 | In distribution | |
| OCPU-TLC | In distribution | |
| OCPU-MML | In distribution | |
| OCPU-LAWV | In distribution | |
| OCPU-GS | In distribution | |
| OCPU-VA1 213248 | In distribution | |
| OCPU-NEMS | In distribution | |
| OCS1 | In distribution | |
| OCPU-SMR | In distribution | |
| OCPU-AMITA | In distribution | |
| OCPU-MRJM | In distribution | |
| OCPU-KPS SD | In distribution | |
| OCPUIO-MAYO | In distribution | |
| OCPU-LIFE | In distribution | |
| OCPU-MMPC | In distribution | |
| OCPU-LBCP TAFL | In distribution | |
| OCPU-UTMB | In distribution | |
| OCPU-PRHS | In distribution | |
| OCPU-PPCP | In distribution | |
| OCPU-ARUP | In distribution | |
| OCPU-SCMF | In distribution | |
| OCPUIO-SWA | In distribution | |
| OCPU-VP | In distribution | |
| OCPU-HNL | In distribution | |
| OCPU-COMM | In distribution | |
| OCS1-KP | In distribution | |
| OCPUIO-WHS WA | In distribution | |
| OCPU-STJH | In distribution | |
| OCPU-BCBY | In distribution | |
| OCPU-HVUW | In distribution | |
| OCPUIO-EML | In distribution | |
| OCPU-GHS | In distribution | |
| OCPU-KPB | In distribution | |
| OCPU-VA1 915908 | In distribution | |
| OCPU-PL-AH2 | In distribution | |
| OCPU-VA1 2333946 | In distribution | |
| OCPUIO-VA1 2334483 | In distribution | |
| OCPUIO-CHMH | In distribution | |
| OCPU-VA1 213261 | In distribution | |
| OCPU-LAGL | In distribution | |
| OCPUIO-VA1 918355 | In distribution | |
| OCPUIO-VA1 2334410 | In distribution | |
| OCPU-MPCP | In distribution | |
| OCPUIO-VA1 5000067 | In distribution | |
| OCPU-VA1 916095 | In distribution | |
| OCIOB | In distribution | |
| OCPUIO-UVM | In distribution | |
| OCPU-THMG | In distribution | |
| OCPU-LAC HUD | In distribution | |
| OCPU-CNT | In distribution | |
| OCPU-EH WH | In distribution | |
| OCPU-CPLH | In distribution | |
| OCPU-VA1 2333714 | In distribution | |
| OCPU-VA1 2233737 | In distribution | |
| OCPU-LBCP RNJ | In distribution | |
| OCPU-LAC USC | In distribution | |
| OCPU-KPP | In distribution | |
| OCPUIO-ALAM | In distribution | |
| OCPUIO-STF | In distribution | |
| OCPU-ALBT | In distribution | |
| OCPU-VA1 5000069 | In distribution | |
| OCPU-AAU | In distribution | |
| OCPU-CCRMC | In distribution | |
| OCPU-SLNY | In distribution | |
| OCPU-CLRL | In distribution | |
| OCPU-SSMMO | In distribution | |
| OCPUIO-GHS | In distribution | |
| OCPU-SPEC | In distribution | |
| OCPUIO-GHS2 | In distribution | |
| OCPUIO-OSU | In distribution | |
| OCPU-VA1 2334515 | In distribution | |
| OCPU-SCC | In distribution | |
| OCPU-VA1 2334384 | In distribution | |
| OCPU-HIMG | In distribution | |
| OCSIO1 | In distribution | |
| OCPUIO-UCI | In distribution | |
| OCPUIO-UAB | In distribution | |
| OCPU-INN | In distribution | |
| OCPU-LBCP HSTX | In distribution | |
| OCPUIO-VA1 213264 | In distribution | |
| OCPUIO-VA1 2334481 | In distribution | |
| OCPU-LBCP BHAL | In distribution | |
| OCPU-VCHS | In distribution | |
| OCPU-VA1 213253 | In distribution | |
| OCPU-VA1 916096 | In distribution | |
| OCPUIO-VA1 213254 | In distribution | |
| OCDL | In distribution | |
| OCPU-HWMG | In distribution | |
| OCPU-BMHL | In distribution | |
| OCPUIO-VA1 918219 | In distribution | |
| OCPU-HH | In distribution | |
| OCPUIO-HFMG | In distribution | |
| OCPUIO-VUMC | In distribution | |
| OCPU-TRU | In distribution | |
| OCPU-UMASS ENVE | In distribution | |
| OCPU-VA1 213251 | In distribution | |
| OCPU-PPG | In distribution | |
| OCPU-VA1 2333543 | In distribution | |
| OCPU-VA1 213259 | In distribution | |
| OCPU-HTPN | In distribution | |
| OCPUIO-VPA | In distribution | |
| OCPUIO-VA1 918497 | In distribution | |
| OCPU-ALVE | In distribution | |
| OCPU-VA1 213255 | In distribution | |
| OCPUIO-VA1 2334487 | In distribution | |
| OCPU-PL-GEM | In distribution | |
| OCPUIO-CPH | In distribution | |
| OCPU-NSMA | In distribution | |
| OCPU-MAYO | In distribution | |
| OCPU-VA1 916046 | In distribution | |
| OCPU-UMO | In distribution | |
| OCPU-UM2 | In distribution | |
| OCPUIO-DMC | In distribution | |
| OCPUIO-MEMHS | In distribution | |
| OCPUIO-VA1 918117 | In distribution | |
| OCPU-VA1 916997 | In distribution | |
| OCPUIO-TRIH | In distribution | |
| OCPU-VA1 2334135 | In distribution | |
| OCPU-VIGA | In distribution | |
| OCPUIO-VA1 918170 | In distribution | |
| OCPU-SJH | In distribution | |
| OCS2-NBQ | In distribution | |
| OCPU-VA1 2334454 | In distribution | |
| OCPU-UMICH | In distribution | |
| OCPUIO-VA1 213253 | In distribution | |
| OCPUIO-HCS | In distribution | |
| OCPU-CCH | In distribution | |
| OCPU-VA1 2333613 | In distribution | |
| OCPU-LBCP AHIL | In distribution | |
| OCPU-UPHT | In distribution | |
| MV5F00-FT | In distribution | |
| OCPUIO-BMHL | In distribution | |
| OCPUIO-PPHS | In distribution | |
| OCPU-VA1 2334125 | In distribution | |
| OCPUIO-VA1 918342 | In distribution | |
| OCPU-LC | In distribution | |
| OCPU-CHL | In distribution | |
| OCPU-VA1 213234 | In distribution | |
| OCPU-DHMC | In distribution | |
| OCPU-MULS | In distribution | |
| OCPU-LBCP NPIL | In distribution | |
| OCPU-MCRMC | In distribution | |
| OCPUIO-ESCL | In distribution | |
| OCPU-SEN | In distribution | |
| OCPUIO-ALVE | In distribution | |
| OCPU-MCC | In distribution | |
| OCPU-KPS WH | In distribution | |
| OCPU-UCI | In distribution | |
| OCPU-LAMV | In distribution | |
| OCPUIO-VA1 213259 | In distribution | |
| OCPU-VA1 213233 | In distribution | |
| OCPU-INTP1 | In distribution | |
| OCPU-KPD3 | In distribution | |
| OCPU-VA1 2334111 | In distribution | |
| OCPU-ASP-KC | In distribution | |
| OCPU-PENN1 | In distribution | |
| OCPUIO-ANMC | In distribution | |
| OCPU-VA1 220600 | In distribution | |
| OCPU-LBCP ACCS | In distribution | |
| OCPU-BWH | In distribution | |
| OCPU-KPS RS | In distribution | |
| OCPU-LLS | In distribution | |
| OCPUIO-VA1 5000026 | In distribution | |
| OCPU-DH | In distribution | |
| OCPU-MTSH | In distribution | |
| OCPU-HMA | In distribution | |
| OCPU-KRMC | In distribution | |
| OCPU-MHDL | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fobt-Chek | Polymedco Cancer Diagnostic Products LLC | 5 |
| Color Stool Collection Kit | Color Diagnostics, LLC | 1 |
| Afias iFOB with AFIAS-50 | Boditech MED Inc. | 1 |
| ichroma™ iFOB | Boditech MED Inc. | 1 |
| ichroma Reader | Boditech MED Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.