DEVICE: LifeSign® MI StatusFirst CK-MB/Myo/TnI card (10743816001331)

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Device Identifier (DI) Information
LifeSign® MI StatusFirst CK-MB/Myo/TnI card
LSC-300-20-02
In Commercial Distribution
LSC-300-20-02
PRINCETON BIOMEDITECH CORPORATION
10743816001331
GS1

1
362917692 *Terms of Use
LifeSign® MI StatusFirst CK-MB/Myo/TnI; 20 Test kit; CE
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
46989 Troponin I IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
46987 Myoglobin IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of myoglobin in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
52995 Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DEA Myoglobin, Fitc, Antigen, Antiserum, Control
MMI Immunoassay Method, Troponin Subunit
JHT Chromatographic Separation, Cpk Isoenzymes
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K981882 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 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
91402d89-91b3-4f70-b9d5-8d916b9d7cb6
June 10, 2022
4
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
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

[?]
8005262125
info@lifesignmed.com
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