DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit (00817302022315)

Device Identifier (DI) Information

CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit
BL-204B
In Commercial Distribution
BL-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
00817302022315
GS1

1
962385787 *Terms of Use
Lp (a) Lipoprotein BL-204B
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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?
53438 Lipoprotein A IVD, kit, nephelometry/turbidimetry
A collection of reagents and other associated materials intended to be used for the quantitative measurement of lipoprotein A lipid in a clinical specimen, using a nephelometry/turbidimetry method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DFC LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180074 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Reagent is stable when stored unopened at 2-8° C until expiration date.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Kit contains 2 R1 and 2 R2 bottles
Total Volume: 18 Milliliter
Total Volume: 7 Milliliter
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Device Record Status

e5a4bf4f-930e-436b-a7b4-038a13758f98
June 05, 2020
2
September 07, 2018
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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

[?]
+1(800)471-7272
ContactSales@CarolinaChemistries.com
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