FDA.reportPublic FDA data

COMPLIANCE GOLD FOB DEVELOPER 8x10mL

Primary DI
00695684742089
Brand
COMPLIANCE GOLD FOB DEVELOPER 8x10mL
Company
GERMAINE LABORATORIES, INC
Model
74208
Device description
Developer solution for use with Compliance Gold FOB tests.
Published
2016-05-17
Public version status
Update
Distribution status
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
00695684742089PrimaryGS10
00695684742081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684742089006956847420896956847420890695684742089
00695684742081006956847420816956847420810695684742081

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
176458115
Device count
8
Lot or batch
true
Expiration date on label
true

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00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
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00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

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