DEVICE: K-ASSAY® IgA Reagent (00816426020092)

Device Identifier (DI) Information

K-ASSAY® IgA Reagent
KAI-013
In Commercial Distribution
KAI-013
KAMIYA BIOMEDICAL COMPANY, LLC
00816426020092
GS1

1
197934250 *Terms of Use
For the quantitative determination of human IgA in serum by immunoturbidimetric assay.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
53759 Total immunoglobulin A (IgA total) 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 detection of total immunoglobulin A (IgA total) in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K993213 000
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 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

612be9dc-f118-4517-b4b5-c698fa52346c
July 06, 2018
3
September 16, 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
No Package DIs found
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
206-575-8068
diagnostics@k-assay.com
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