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
00817302023053
GS1

1
962385787 *Terms of Use
DBIL (Direct Bilirubin) 4 x 300 tests
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CIG DIAZO COLORIMETRY, BILIRUBIN
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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
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 23 Milliliter
Total Volume: 64 Milliliter
Device Size Text, specify: Kit contains 4 R1 bottles, 4 R2 bottles and 1 package insert
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Device Record Status

b33d2f25-dc6a-42ef-85f1-d40030df6eef
August 14, 2023
3
October 17, 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

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