FDA.reportPublic FDA data

OC-Light S

Primary DI
00816917025681
Brand
OC-Light S
Company
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Model
FBPUS-EHICH
Device description
Personal Use Kit OC-Light S, for Emanate Health Inter-Comm Hospital
Published
2022-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143325000OC-Light S FITEiken Chemical Co., Ltd.2015-08-20KHE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816917025681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816917025681008169170256818169170256810816917025681

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816917028101OC-AutoOCPUIO-VA1 9160762026-09-04
00816917028088OC-AutoOCPUIO-VA1 23341112026-08-21
00816917028095OC-AutoOCPUIO-MCFL2026-08-21
00816917027845OC-AutoOCPUIO-YNHM2026-08-07
00816917027852OC-AutoOCPU-THSJI2026-08-07
00816917027869OC-AutoOCPUIO-HVMA2026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841824105737ClarityW.H.P.M. INC.KHE2026-10-08
00841824105720ClarityW.H.P.M. INC.KHE2026-10-06
06950996042154One StepZhejiang Orient Gene Biotech Co.,Ltd.KHE2026-07-26
06950996091541One StepZhejiang Orient Gene Biotech Co.,Ltd.KHE2026-07-26
86950996095842Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.KHE2026-07-26
06950996002004Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.KHE2026-07-22
00810173655873One StepHealgen Scientific Limited Liability CompanyKHE2026-06-23
00810173655880One StepHealgen Scientific Limited Liability CompanyKHE2026-06-23
00816862028324WELLlife™ WONDFO USA CO., LTD.KHE2026-05-15
00816917027821OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2026-03-25
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestTECO DIAGNOSTICSKHE2026-01-30
10722066011338Rapid ResponseBTNX IncKHE2026-01-02
20722066011335Rapid ResponseBTNX IncKHE2026-01-02
00816917027173OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2025-05-02
10722355002894hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355002900hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
10722355003068hema-screen SPECIFIC GOLDImmunostics Company, IncKHE2025-04-16
00850036464662Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
20850036464666Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
00816862025972WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
10816862025979WELLlife™WONDFO USA CO., LTD.KHE2024-12-24
00816917026374OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-06-28
00850054026590QMedix™Diagnostic Automation, Inc.KHE2024-05-10
10023513132157Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-04-26
00816917026244OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-02-19
10023513132140Reese's ColoTestREESE PHARMACEUTICAL COMPANYKHE2024-01-23
00816917026121OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-10-26
00810143620023GenaCheck Rapid Self-Test Kit for FOBGenabio Diagnostics Inc.KHE2023-10-06
10722066007102Rapid ResponseBTNX IncKHE2023-06-15
00722066004302Rapid ResponseBTNX IncKHE2023-06-15