FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424

Primary DI
00817302020847
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
AU-424
Catalog number
AU-424
Device description
BUP (Buprenorphine)
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGENZYME IMMUNOASSAY, OPIATES
DLJCALIBRATORS, DRUG SPECIFIC
LASDRUG SPECIFIC CONTROL MATERIALS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DLJCalibrators, Drug SpecificClinical Toxicology2
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302020847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020847008173020208478173020208470817302020847

GMDN Terms#

Term, Definition table
TermDefinition
Buprenorphine IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume23Milliliter
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Kit can be expected to perform satisfactorily until the expiration date if stored in the refrigerator at 2-8°C.
Special Storage Condition, Specify00Reagent is stable on board a clinical analyzer for 28 days when stored at 2 to 8°C
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
962385787
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302020274CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227ST227ST2272016-09-01
00817302020281CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT BL-227BL227BL2272016-09-01
00817302020298CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227AU-227AU-2272016-09-01
00817302020304CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227CC227CC2272016-09-01
00817302022964CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227DT227DT2272016-10-17
00817302020182CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT BL-224BL-224.BL-224.2016-09-01
00817302020199CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 ALBUMIN REAGENT KIT Product No. ST224ST224ST2242016-09-01
00817302020205CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT. KIT AU-224AU-224AU-2242016-09-01
00817302020212CAROLINA LIQUID CHEMISTRIES CORP.® ALB (BCG) CC224CC224CC2242016-09-01
00817302020229CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214CC214CC2142016-09-01
00817302020946CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214AU-214AU-2142016-09-01
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224DT224DT2242016-10-17
00817302021912CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT BL-419BBL419BBL419B2016-09-01
00817302020786CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425BL425BL4252016-09-01
00817302020809CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425AU-425AU-4252016-09-01
00817302020816CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425DT425DT4252016-09-01
00817302021066CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412AU-412AU-4122016-09-01
00817302021127CAROLINA LIQUID CHEMISTRIES CORP.® BARB RGT. KIT AU-417AU-417AU-4172016-09-01
00817302021189CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418AU-418AU-4182016-09-01
00817302021257CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT AU-413AU-413AU-4132016-09-01

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