DEVICE: CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224 (00817302020182)
Device Identifier (DI) Information
CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224
BL-224.
In Commercial Distribution
BL-224.
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL-224.
In Commercial Distribution
BL-224.
CAROLINA LIQUID CHEMISTRIES CORPORATION
ALB (Albumin) 3 X 160 tests
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? |
---|---|---|---|---|
53599 | Albumin IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of albumin in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Reagent is stable on board a clinical analyzer for 30 days |
Special Storage Condition, Specify: Reagent is stable until expiration date on kit when stored at 8 to 30° |
Storage Environment Temperature: between 8 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 40 Milliliter |
Device Size Text, specify: Kit contains 3R1 bottles and 1 package insert |
Device Record Status
3923c2da-aaf9-466f-a2c6-6ca9a62d45e4
August 14, 2023
4
September 01, 2016
August 14, 2023
4
September 01, 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 |
---|---|---|---|---|---|
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