DEVICE: Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System (B110AN10060)

Device Identifier (DI) Information

Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System
AN-1006
In Commercial Distribution
AN-1006
MBL Bion
B110AN10060
HIBCC

1
024824641 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Multiple antinuclear antibody (ANA) screening 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 for one or multiple antinuclear antibodies (ANA) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K872845 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: less than 8 Degrees Celsius
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Clinically Relevant Size

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

74658792-e30f-418d-82e0-4bfc8db4079c
July 06, 2018
3
September 12, 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

[?]
847-544-5044
bion@mblintl.com
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