CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421 DT421

GUDID 00817302021851

ETHA (Alcohol) w/ cal 2 x 500 tests

CAROLINA LIQUID CHEMISTRIES CORPORATION

Ethanol (ETOH) IVD, kit, enzyme spectrophotometry

Primary Device ID	00817302021851
NIH Device Record Key	f5a15a0f-aa4e-4dc2-89f7-d70da38c265a
Commercial Distribution Status	In Commercial Distribution
Brand Name	CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT KIT Product No. DT421
Version Model Number	DT421
Catalog Number	DT421
Company DUNS	962385787
Company Name	CAROLINA LIQUID CHEMISTRIES CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	true
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com
Phone	+1(800)471-7272
Email	ContactSales@CarolinaChemistries.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0
Total Volume	46.5 Milliliter
Total Volume	5 Milliliter
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Reagent is stable when stored at 2-8° C until expiration date
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817302021851 [Primary]

FDA Product Code

DMT	ENZYMATIC METHOD, ALCOHOL DEHYDROGENASE, ULTRAVIOLET

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-01

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