FDA.reportPublic FDA data

ADS Medical

Primary DI
00811925030009
Brand
ADS Medical
Company
W.H.P.M. INC.
Model
T1-CK30-ADSM
Device description
ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with 50 Mailers
Published
2018-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHEReagent, Occult Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811925030009PrimaryGS10
00811925030016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811925030009008119250300098119250300090811925030009
00811925030016008119250300168119250300160811925030016

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602085672
Device count
30
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841824105577ECOIIECOII-6664ECOII-66642026-03-19
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00811925030023ADS MedicalT1-CK30T-ADSM2018-03-29
00811925030030ADS MedicalT1-CK50-ADSM2018-03-29
00811925030047ADS MedicalT1-CT30-ADSM2018-03-29
00811925030054ADS MedicalT1-CT50-ADSM2018-03-29
00811925030061ADS MedicalT1-TB30-ADSM2018-03-29
00811925030078ADS MedicalT1-TB50-ADSM2018-03-29
00841824105706N/AW944W9442025-12-04
00841824105690EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105652N/AWMA500-25WMA500-252025-06-13
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105560ECOIIECOII-07144ECOII-071442024-08-22
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
10841824104737EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105416N/AW4374W43742024-06-14
00841824105409N/AW4374W43742024-06-14
00841824105508ECOIIECOII-4104 W/AD2ECOII-4104 W/AD22024-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00816917026015OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-03-14
00816917025728OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-18
00816917025704OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-08
00816917025681OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-03-28
00816917025582OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-12-20
30080196165142MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
10080196165148MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
00816917025506OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-10-14