FDA.report

CARDINAL HEALTH

Primary DI
10885380183645
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH25
Catalog number
CH25
Device description
CH25 Cardinal Health H. pylori Rapid Test
Published
2022-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LYRHelicobacter pylori

Product Code Classifications

CodeDeviceSpecialtyClass
LYRHelicobacter PyloriMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885380183642PrimaryGS10
10885380183645Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088538018364220885380183642
1088538018364510885380183645

GMDN Terms

TermDefinition
Helicobacter pylori antigen IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from Helicobacter pylori bacteria 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 for detecting infection with H. pylori which is associated with gastroduodenal disorders such as active chronic gastritis and gastric/duodenal ulcers. It is not intended to be used for self-testing.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

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05391516747516Trinity BiotechCLARK LABORATORIES, INC.LYR2019-11-05
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