DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit (00817302022308)
Device Identifier (DI) Information
CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit
AU-204B
In Commercial Distribution
AU-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-204B
In Commercial Distribution
AU-204B
CAROLINA LIQUID CHEMISTRIES CORPORATION
Lp (a) Lipoprotein AU-204B
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DFC | LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K180074 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 45 Milliliter |
Total Volume: 15 Milliliter |
Device Size Text, specify: Kit contains 3 R1 and 3 R2 bottles |
Device Record Status
df94dcf4-98c9-4544-9a26-4bc701e8e2fa
June 05, 2020
2
September 07, 2018
June 05, 2020
2
September 07, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)471-7272
ContactSales@CarolinaChemistries.com
ContactSales@CarolinaChemistries.com