FDA.reportPublic FDA data

hema-screen SPECIFIC

Primary DI
10722355001071
Brand
hema-screen SPECIFIC
Company
Immunostics Company, Inc
Model
HSSP-25
Device description
Immunological Fecal Occult Blood test
Published
2016-09-21
Public version status
Update
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
20722355001078PackageGS110In Commercial Distribution
10722355001071PrimaryGS10
80722355001070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2072235500107820722355001078
1072235500107110722355001071
8072235500107080722355001070

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(732)918-0770technical@immunostics.com

Regulatory Flags#

DUNS number
119214195
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10722355002894hema-screen SPECIFIC GOLDHSGD-25HSGD-252025-04-16
10722355002900hema-screen SPECIFIC GOLDHSGDCAS-25HSGDCAS-252025-04-16
10722355003068hema-screen SPECIFIC GOLDHSGDENV-20HSGDENV-202025-04-16
10722355001002hema-screenHS-502016-09-23
10722355001019hema-screenHS-1002016-09-23
10722355001026hema-screenHS-10002016-09-23
10722355001033hema-screenHS-342016-09-23
10722355001040hema-screenHSPP-502016-09-23
10722355001057hema-screen STATHSTAT-502016-09-23
10722355001095hema-screen SPECIFICHSSPCAS-252016-09-21
10722355001101hema-screen SPECIFICHSSPENV-202016-09-21
10722355001125hema-screenHSDV-82016-09-23
10722355001255Detector MonoIDM-252016-09-22
10722355001453Detector PersonalIDP-32016-09-20
10722355001668Detector Strep AIST-501-OBC33IDSTREP-252016-09-21
10722355002016Detector H. pyloriIHP-102016-09-22
10722355002023Detector H. pyloriIHP-302016-09-22
10722355002146hema-screen Triple 335HSTR-335CS2016-09-23
10722355002221Detector UA 10IDU-102016-09-26
10722355002238Detector UA 5IDU-5OB2016-09-25

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
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