DEVICE: Detector H. pylori (10722355002016)

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Device Identifier (DI) Information

Detector H. pylori
IHP-10

IMMUNOSTICS COMPANY, INC
10722355002016
GS1
10
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of immunoglobulin G (IgG) antibodies to Helicobacter pylori in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses, and is also available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment. Infection with H. pylori is associated with gastroduodenal disorders such as active chronic gastritis, gastric, and duodenal ulcers.
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FDA Product Code

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Product Code Product Code Name
LYR Helicobacter pylori
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 22, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20722355002013 10 10722355002016 In Commercial Distribution Case of 10
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 80722355002015 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(732)918-0770
technical@immunostics.com
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