FDA.reportPublic FDA data

Color Stool Collection Kit

Primary DI
00860014139338
Brand
Color Stool Collection Kit
Company
Color Diagnostics, LLC
Model
1.0
Published
2025-06-09
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014139338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014139338008600141393388600141393380860014139338

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118772507
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014139307Color Saliva Collection Kit1.02025-06-09
00860014139314Color Urine Collection Kit1.02025-06-09
00860014139321Color Blood Collection Kit (Upper Arm)1.02025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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