FDA.reportPublic FDA data

OC-Auto

Primary DI
00816917027838
Brand
OC-Auto
Company
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Model
OCPUIO-DCRV
Device description
OC-Auto SENSOR io Personal Use Kit for DCRV
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00816917027838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816917027838008169170278388169170278380816917027838

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 Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
078413594
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855574005285BTA TRAK6621502016-09-23
00855574005292BTA TRAK6621602016-09-23
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
00816917027708OC-AutoOCPUIO-HCS2026-02-06
00816917027715OC-AutoOCPUIO-HFMG2026-02-06
00816917027722OC-AutoOCPUIO-CHMH2026-02-06
00816917027739OC-AutoOCPUIO-VA1 9160992026-02-06
00816917027746OC-AutoOCPU-LBCP AHIL2026-02-06
00816917027692OC-AutoOCPUIO-HTPN2026-01-16
00816917027685OC-AutoOCPUIO-VA1 2202402026-01-12
00816917027630OC-AutoOCPUIO-VA1 23341352026-01-09
00816917027647OC-AutoOCPUIO-VA1 9160962026-01-09
00816917027654OC-AutoOCPUIO-VA1 9160972026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00816917027517OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027524OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027531OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027548OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027555OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027562OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027579OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027586OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027593OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07
00816917027609OC-AutoPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOOX2025-11-07