FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT MR419B

Primary DI
00817302021592
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® OXYC RGT. KIT MR419B
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
MR419B
Catalog number
MR419B
Device description
OXYC (Oxycodone) 2 x 100 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LASDRUG SPECIFIC CONTROL MATERIALS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302021592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302021592008173020215928173020215920817302021592

GMDN Terms#

Term, Definition table
TermDefinition
Oxycodone IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of oxycodone in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter
Total Volume20Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable when stored at 2-8° C until expiration date
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302022353Carolina Liquid Chemistries Corp. Basic Multi-Drug Control SetCC4492023-03-27
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCLCE11062023-03-10
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCLCF650252023-03-10
00817302024678CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445CC445CC4452022-12-03
00817302024654Caldon Biotech Aldolase ReagentCALD-015CALD-0152022-11-30
00817302024661Caldon Biotech Serum Aldolase ControlsCOAL-015COAL-0152022-11-30
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240AU-240AU-2402022-10-18
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220AU-220AU-2202022-08-19
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218AU-240AU-2402022-08-19
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618AU-618AU-6182022-08-19
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621AU-621AU-6212022-08-19
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661AU-661AU-6612022-08-19
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209BL209BL2092022-08-19
00817302024166CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211BL211BL2112022-08-19
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212BL212BL2122022-08-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B800OPIBENZO2V4UFGML0OPI PLUS BENZO LEVEL 2 V4UTAK LABORATORIES, INC.LAS2026-05-26
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-03-03
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4UTAK LABORATORIES, INC.LAS2026-02-25
B800ETH177WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2UTAK LABORATORIES, INC.LAS2026-02-06
B800ANLCCALMFFCCO5 ANLC CALUTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2UTAK LABORATORIES, INC.LAS2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX5ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B800MOR225UKP5MORPHINE 225 NG/MLUTAK LABORATORIES, INC.LAS2026-01-16
B800AMPH60V2WBCP5AMPH PLUS 60 NG/ML V2UTAK LABORATORIES, INC.LAS2026-01-13
B800DAUL3UFVMCI5 DRUGS OF ABUSE LEVEL 3UTAK LABORATORIES, INC.LAS2026-01-13
B800FENTUFODX5 FENTANYL PLUSUTAK LABORATORIES, INC.LAS2026-01-06
00812101031667ARK™ Ketamine II Control (25/75)ARK DIAGNOSTICS INCLAS2025-12-27
00812101031674ARK™ Ketamine II Control (75/125)ARK DIAGNOSTICS INCLAS2025-12-27
B800AMPQC1URIH5AMPHETAMINE LEVEL 1UTAK LABORATORIES, INC.LAS2025-12-15
B800AMPQC2URIH5AMPHETAMINE LEVEL 2UTAK LABORATORIES, INC.LAS2025-12-15
B800TRAM400UDEAW5TRAMADOL 400 NG/MLUTAK LABORATORIES, INC.LAS2025-09-26