Hemosure® Accu-Reader®

Primary DI
00817763022770
Brand
Hemosure® Accu-Reader®
Company
W.H.P.M. INC.
Model
A100
Device description
Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader® A100 is comprised of Hemosure® Accu-Reader® A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader® A100 Control and Hemosure® Accu-Reader® A100 Calibration Cartridge Kit.
Published
2023-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817763022770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817763022770008177630227708177630227700817763022770

GMDN Terms#

Term, Definition table
TermDefinition
Faecal occult blood IVD, kit, rapid ICT, 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 and/or transferrin) within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
602085672
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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