FDA.report

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) 2 x 625 tests
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DLJCALIBRATORS, DRUG SPECIFIC

Product Code Classifications

CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817302020847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302020847008173020208478173020208470817302020847

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Total Volume23Milliliter
Total Volume60Milliliter

Storage And Handling

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

Contacts

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

Regulatory Flags

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218BL218BL2182022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

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