FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740005757
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
3L42-20
Catalog number
03L4220
Device description
Ecstasy
Published
2016-06-06
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
DLJCALIBRATORS, DRUG SPECIFIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
DLJCalibrators, Drug SpecificClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012109000
K012110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012109000DRI ECSTASY URINE CALIBRATORSMicrogenics Corp.2001-08-27DLJ
K012110000DRI ECSTASY ENZYME IMMUNOASSAYMicrogenics Corp.2001-08-27DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740005757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740005757003807400057573807400057570380740005757

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group 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 the amphetamine and/or methamphetamine group(s) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740019730ARCHITECT9D96-2109D96212016-06-06
00380740225742ARCHITECT08G983008G98302026-10-14
00380740225759ARCHITECT04J623004J62302026-10-14
00380740019747ARCHITECT9D97-2109D97212016-06-06
00380740000202ARCHITECT1E01-2101E01212016-06-06
00380740019761ARCHITECT9D99-2109D99212016-06-06
00380740138738ARCHITECT6P30-2106P30212016-09-09
00380740225575ARCHITECT04P553104P55312026-08-22
00380740138783Alinity09P710109P71012023-11-16
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31

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Primary DI, Brand, Company table
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B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
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B07609730LZI Fentanyl Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2026-07-17
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
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00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
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00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
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00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
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