FDA.reportPublic FDA data

COMPLIANCE GOLD iFOB FC

Primary DI
00695684740344
Brand
COMPLIANCE GOLD iFOB FC
Company
GERMAINE LABORATORIES, INC
Model
74034
Device description
Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. Full Compliance.
Published
2016-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00695684740344PrimaryGS10
00695684740341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684740344006956847403446956847403440695684740344
00695684740341006956847403416956847403410695684740341

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
176458115
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684410117SAFECUP III MULTIDRUG 11410112022-08-17
00695684444310SAFECUP III 13 PANEL 444332022-08-17
00695684754075Mosie Baby Ovulation Test754072019-10-21
00695684957018Mosie Baby Pregnancy Test957012019-10-21
06956847540756Mosie Baby Ovulation Test754072019-10-21
06956848940166Mosie Baby Pregnancy Test957012019-10-21
00695684511005AIMSTRIP 10-SG511002016-04-21
00695684511111AIMSTRIP US-11511112016-04-27
00695684544003AIMSTRIP US-4544002016-04-27
00695684551001AIMSTRIP US-5551002016-04-27
00695684552008AIMSTRIP US-5B552002016-04-27
00695684591007AIMSTRIP US-9591002016-04-27
00695684131128KETONE SERUM CONTROLS131122019-02-06
00695684730253STREPAIM730252019-02-06
00695684010003BRUCELLA ABORTUS ANTIGEN10002016-04-12
00695684010027BRUCELLA MELITENSIS ANTIGEN10022016-04-21
00695684011000BRUCELLA ABORTUS ANTISERUM11002016-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestTECO DIAGNOSTICSKHE2026-01-30
20722066011335Rapid ResponseBTNX IncKHE2026-01-02
00816917027173OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2025-05-02
20850036464666Red TunicaRodimedi & Associates, Inc.KHE2025-03-14
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
00722066004302Rapid ResponseBTNX IncKHE2023-06-15
00816917026015OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2023-03-14
00816917025728OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2022-04-18
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00816917025582OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-12-20
10080196165148MedlineMEDLINE INDUSTRIES, INC.KHE2021-10-29
00816917025506OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2021-10-14
B224SB191TRI-SLIDE PATIENT ENVELOPE KITCENOGENICS CORPORATIONKHE2021-05-27
B224SB201TRI-SLIDE STOOL BLOOD TESTCENOGENICS CORPORATIONKHE2021-05-27
B224SB211PROFESSIONAL SINGLE SLIDE KITCENOGENICS CORPORATIONKHE2021-05-27
00816917025223OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2020-10-26
00083059010015EZ Detect Fecal Occult Blood TestBIOMERICA, INC.KHE2020-07-01
00083059100013EZ Detect Colon Disease TestBIOMERICA, INC.KHE2020-07-01
00816917025063OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2020-04-20
00816917025087OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2020-04-20
00816917025056OC-Light SPOLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCKHE2020-03-20
10304040102517Henry ScheinHENRY SCHEIN, INC.KHE2020-02-24