FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® PCP RGT. KIT ST414

Primary DI
00817302021639
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® PCP RGT. KIT ST414
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
ST414
Catalog number
ST414
Device description
PCP (Phencyclidine) 3 x 375 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
LCMEnzyme immunoassay, phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302021639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302021639008173020216398173020216390817302021639

GMDN Terms#

Term, Definition table
TermDefinition
Phencyclidine (PCP) 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 phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

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
10810173655962HealgenHealgen Scientific Limited Liability CompanyLCM2026-03-11
10810173655566HealgenHealgen Scientific Limited Liability CompanyLCM2026-02-04
00810173654920HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
00810173655071HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173655085HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173654774HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
10810173654798HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
00812101031599ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031605ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031612ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031995ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
10810173654538Healgen Healgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654576HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654637HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
08500130357170Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035809Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035878Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035076Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-09-11
10816862026785Prime ScreenWONDFO USA CO., LTD.LCM2025-07-03
10816862026358SAFElife™WONDFO USA CO., LTD.LCM2024-12-24
10815845023162SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LCM2024-12-17
00817763022510First Sign®HEMOSURE INC.LCM2024-10-16
00812203030780DrugSmart CupCHEMTRON BIOTECH INCLCM2024-07-29
10810124273245SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)ALERE SAN DIEGO, INC.LCM2023-12-15
00858886006827Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLCM2023-10-20
00817815021119CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.LCM2023-08-23
10690286000763PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.LCM2023-08-01
30817405023821iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405023883iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405021711iScreen™Instant Technologies, Inc.LCM2023-02-07