DEVICE: KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT (B126KR65650)

Device Identifier (DI) Information

KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
KR6565
In Commercial Distribution
KR6565
KRONUS, INC.
B126KR65650
HIBCC

1
181070814 *Terms of Use
The KRONUS VGCC Antibody RIA Assay Kit is a radioimmunoassay for the semi-quantitative determination of antibodies to voltage gated calcium channels (VGCC) in human serum.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a radioimmunoassay method.
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FDA Product Code

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Product Code Product Code Name
PAF Voltage Gated Calcium Channel (Vgcc) Antibody Assay
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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

08125dd8-0761-408e-88bd-8d98ba05846f
March 29, 2018
2
September 23, 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
No Package DIs found
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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: No Unit of Use DI Numbers Found 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

[?]
800-457-6687
kronus@kronus.com
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