FDA.reportPublic FDA data

OC-Auto

Primary DI
00816917027869
Brand
OC-Auto
Company
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Model
OCPUIO-HVMA
Device description
OC-Auto SENSOR io Personal Use Kit for HVMA
Published
2026-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OOXAutomated Occult Blood Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOXAutomated Occult Blood AnalyzerHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191147000OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd.2020-01-02OOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816917027869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816917027869008169170278698169170278690816917027869

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Regulatory Flags#

DUNS number
078413594
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816917027845OC-AutoOCPUIO-YNHM2026-08-07
00816917027852OC-AutoOCPU-THSJI2026-08-07
00816917027876OC-AutoOCPUIO-IUHPL2026-08-07
00816917027883OC-AutoOCPUIO-VA1 23341022026-08-07
00816917027890OC-AutoOCPUIO-VA1 23343372026-08-07
00816917027906OC-AutoOCPUIO-LGH2026-08-07
00816917027913OC-AutoOCPUIO-UMICH2026-08-07
00816917027920OC-AutoOCPUIO-PHE2026-08-07
00816917027937OC-AutoOCPUIO-HNL2026-08-07
00855574005285BTA TRAK6621502016-09-23
00855574005292BTA TRAK6621602016-09-23
00816917027838OC-AutoOCPUIO-DCRV2026-04-03
00816917027821OC-Light SFBPUS-MCWI2026-03-25
00816917027814OC-AutoOCPUIO-STF2026-03-18
00816917027784OC-AutoOCPUIO-GHS12026-03-13
00816917027791OC-AutoOCPUIO-GHS22026-03-13
00816917027807OC-AutoOCPUIO-DHW2026-03-13
00816917027760OC-AutoOCPUIO-ANMC2026-02-27
00816917027777OC-AutoOCPUIO-VA1 9158942026-02-27
00816917027753OC-AutoOCPUIO-GSJH2026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816917027845OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027852OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027876OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027883OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027890OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027906OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027913OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027920OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027937OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-08-07
00816917027838OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-04-03
00816917027814OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-18
00816917027784OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027791OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027807OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-03-13
00816917027760OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-27
00816917027777OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-27
00816917027753OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-13
00816917027708OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027715OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027722OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027739OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027746OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-02-06
00816917027692OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-16
00816917027685OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-12
00816917027630OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027647OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027654OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027661OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027678OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2026-01-09
00816917027623OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-21