FDA.reportPublic FDA data

DENCOCCULT™ III

Primary DI
10859035006023
Brand
DENCOCCULT™ III
Company
ALERE NORTH AMERICA, LLC
Model
L103E
Published
2016-09-24
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
10859035006023PrimaryGS10
00859035006026Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085903500602310859035006023
00859035006026008590350060268590350060260859035006026

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, rapid colorimetric, 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) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly 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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-441-7440ts.scr@alere.com

Regulatory Flags#

DUNS number
826027364
Device count
100
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859035006016IMMUNEX CRP® 71S22016-09-24
10859035006238Acceava® Mono Cassette924072016-09-24
10859035006214Wampole ColorCard® ASO 470502018-09-24
10859035006221Wampole ColorCard® Streptozyme® 460502018-09-24
10859035006009RHEUMATEX®34S22016-09-24
10859035006030IMPACT RPR™ TEST KIT (50 TESTS)60C1 2016-09-24
10859035006047IMPACT RPR™ TEST KIT (150 TESTS)60C22016-09-24
10859035006054IMPACT RPR™ TEST KIT (500 TESTS)60C32016-09-24
10859035006061IMPACT RPR™ TEST KIT (5000 TESTS)60C42016-09-24
10859035006078IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS)60C62016-09-24
10859035006085IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML61C02016-09-24
10859035006092IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML61C12016-09-24
10859035006108IMPACT RPR™ DRY CONTROL CARDS 10 EA61C22016-09-24
10859035006115IMPACT RPR™ LIQUID CONTROL 3 X 1 ML61C32016-09-24
10859035006122IMPACT RPR™ PIPETS/STIRRERS 500 EA61C42016-09-24
10859035006139IMPACT RPR™ 10 WELL TEST CARDS 300 EA61C52016-09-24
10859035006146IMPACT RPR™ 30 WELL TEST CARDS 100 EA61C72016-09-24
10859035006153IMPACT RPR™ NEEDLE/SHEATH 10 EA61C82016-09-24
10859035006160IMPACT RPR™ DISPENSING BOTTLES 10 EA61C92016-09-24
10859035006177IMPACT RPR™ PIPETS/STIRRERS 250 EA62C42016-09-24

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