FDA.reportPublic FDA data

Red Tunica

Primary DI
00850036464662
Brand
Red Tunica
Company
Rodimedi & Associates, Inc.
Model
RT-20132
Catalog number
RT-20132
Device description
The RedTunica™ One Step iFOB is a rapid immunoassay for the qualitative detection of human occult blood in human fecal specimens.
Published
2025-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00850036464662PrimaryGS10
20850036464666Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036464662008500364646628500364646620850036464662
2085003646466620850036464666

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Contacts#

Phone, Email table
PhoneEmail
18883159472jrodriguez@rodimedi.com

Regulatory Flags#

DUNS number
785417726
Device count
25
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810160810377Red TunicaRT-20134RT-201342025-03-14
00810160810414Red TunicaRT-20130RT-201302025-03-14
00810160810360Red TunicaRT-20134RT-201342025-03-14
10810160810411Red TunicaRT-20130RT-201302025-03-14
20850036464666Red TunicaRT-20132RT-201322025-03-14
00810160810001Red TunicaRT-34145RT-341452024-06-14
00810160810032Red TunicaRT-34148RT-341482024-06-14
00810160810063Red TunicaRT-34151RT-341512024-06-14
00810160810094Red TunicaRT-34154RT-341542024-06-14
00810160810124Red TunicaRT-34157RT-341572024-06-14
00810160810155Red TunicaRT-34163RT-341632024-06-14
00850036464808Red TunicaRT-34166RT-341662024-06-14
00810160810018Red TunicaRT-34145RT-341452024-06-14
00810160810049Red TunicaRT-34148RT-341482024-06-14
00810160810070Red TunicaRT-34151RT-341512024-06-14
00810160810100Red TunicaRT-34154RT-341542024-06-14
00810160810131Red TunicaRT-34157RT-341572024-06-14
00810160810162Red TunicaRT-34163RT-341632024-06-14
00850036464815Red TunicaRT-34166RT-341662024-06-14
00850036464440Red TunicaRT-37297RT-372972024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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00816917026244OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2024-02-19
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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
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00816917026015OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-03-14
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