DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® DBIL REAGENT PRODUCT NO. DT229 (00817302023053)
Device Identifier (DI) Information
CAROLINA LIQUID CHEMISTRIES CORP.® DBIL REAGENT PRODUCT NO. DT229
DT229
In Commercial Distribution
DT229
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT229
In Commercial Distribution
DT229
CAROLINA LIQUID CHEMISTRIES CORPORATION
DBIL (Direct Bilirubin) 4 x 300 tests
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
Yes | |
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? |
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53233 | Conjugated (direct) bilirubin IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of conjugated (direct) bilirubin in a clinical specimen, using a spectrophotometry method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CIG | DIAZO COLORIMETRY, BILIRUBIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Reagent is stable when stored at 15-30° C until expiration date |
Storage Environment Temperature: between 8 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 23 Milliliter |
Total Volume: 64 Milliliter |
Device Size Text, specify: Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert |
Device Record Status
b33d2f25-dc6a-42ef-85f1-d40030df6eef
August 14, 2023
3
October 17, 2016
August 14, 2023
3
October 17, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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