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…

Registry build 21.09.26

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.

1manufacturer
727catalogue numbers in this listing

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code OOX
Manufacturer City Province Registered as Device types
W.h.p.m. Bioresearch & Technology Co., Ltd. Beijing Beijing Manufacturer 37

Record

Regulatory record for OC-Auto
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

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 numbers for OC-Auto
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.

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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer