DEVICE: Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test (B103A25CS30021)

Device Identifier (DI) Information

Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
CS3002
In Commercial Distribution
CS3002
International Point of Care Incorporated
B103A25CS30021
HIBCC

25
243942278 *Terms of Use
Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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 cardiac marker IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative detection of one or a combination of cardiac markers in a clinical specimen, within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T. This test is commonly used in the laboratory or in point-of-care analyses.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DEA Myoglobin, Fitc, Antigen, Antiserum, Control
MMI Immunoassay Method, Troponin Subunit
JHT Chromatographic Separation, Cpk Isoenzymes
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

f67d07bc-dfd4-46cf-8165-19509b9e8123
March 29, 2018
2
September 15, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: B103CS30020 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
416-847-2777
customerservice@ipocdx.com
CLOSE