FDA.reportPublic FDA data

COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES

Primary DI
00695684742508
Brand
COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 50 TRI-SLIDES
Company
GERMAINE LABORATORIES, INC
Model
74250
Device description
Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens.
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
00695684742508PrimaryGS10
06956847425081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684742508006956847425086956847425080695684742508
06956847425081069568474250816956847425081

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, chromogenic, 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 a chromogenic 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
50
Lot or batch
true
Expiration date on label
true

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