FDA.report

COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 100 SINGLE SLIDES

Primary DI
00695684742003
Brand
COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 100 SINGLE SLIDES
Company
GERMAINE LABORATORIES, INC
Model
74200
Device description
Fecal occult blood rapid assay for the qualitative detection of occult blood in human stool samples.
Published
2016-05-17
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

Related Records

Product Codes

CodeName
KHEReagent, Occult Blood

Product Code Classifications

CodeDeviceSpecialtyClass
KHEReagent, Occult BloodHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00695684742003PrimaryGS10
00695684742001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684742003006956847420036956847420030695684742003
00695684742001006956847420016956847420010695684742001

GMDN Terms

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

Regulatory Flags

DUNS number
176458115
Device count
100
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

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