DEVICE: hema-screen ER developer (10722355002559)

Device Identifier (DI) Information

hema-screen ER developer
HSDVER-8
In Commercial Distribution

IMMUNOSTICS COMPANY, INC
10722355002559
GS1

8
119214195 *Terms of Use
Fecal Occult Blood Reagent, Guaiac
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Faecal occult blood IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).
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FDA Product Code

[?]
Product Code Product Code Name
KHE REAGENT, OCCULT BLOOD
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7ccd8009-58d6-4342-bdf8-76f2a4ce06aa
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20722355002556 10 10722355002559 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

[?]
Unit of Use DI Number: 80722355002558 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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