FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412

Primary DI
00817302021066
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT AU-412
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
AU-412
Catalog number
AU-412
Device description
AMPH (Amphetamines)
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
DKZENZYME IMMUNOASSAY, AMPHETAMINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302021066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302021066008173020210668173020210660817302021066

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 a specific amphetamine 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, 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
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
00817302020847CAROLINA LIQUID CHEMISTRIES CORP.® BUP RGT. KIT AU-424AU-424AU-4242016-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23