Caldon Biotech Aldolase Reagent CALD-015

GUDID 00817302024654

Aldolase

CAROLINA LIQUID CHEMISTRIES CORPORATION

Aldolase IVD, reagent
Primary Device ID00817302024654
NIH Device Record Key116442a3-512f-4411-9896-ea3f8a9314fa
Commercial Distribution StatusIn Commercial Distribution
Brand NameCaldon Biotech Aldolase Reagent
Version Model NumberCALD-015
Catalog NumberCALD-015
Company DUNS962385787
Company NameCAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com
Phone+1(877)722-8910
Emaillorlow@carolinachemistries.com

Device Dimensions

Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0
Total Volume15 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817302024654 [Primary]

FDA Product Code

CJCFRUCTOSE-1, 6-DIPHOSPHATE AND NADH (U.V.), ALDOLASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

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00817302024678 - CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC4452022-12-12 Oxidant Reagent (CC445)
00817302024654 - Caldon Biotech Aldolase Reagent2022-12-08Aldolase
00817302024654 - Caldon Biotech Aldolase Reagent2022-12-08 Aldolase
00817302024661 - Caldon Biotech Serum Aldolase Controls2022-12-08 Aldolase Controls
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