FDA.report

ARCHITECT

Primary DI
00380740001780
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1P33-25
Catalog number
01P3325
Device description
ARCHITECT iPhenobarbital Reagent Kit
Published
2016-06-06
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
00380740001780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740001780003807400017803807400017800380740001780

GMDN Terms

TermDefinition
Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug phenobarbital in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
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 DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740023386ARCHITECT03M740103M74012026-01-24
00380740225155ARCHITECT04J622804J62282026-01-03
00380740225162ARCHITECT08G982808G98282026-01-03
00380740224523ARCHITECT04P552804P55282026-01-01
00380740224530ARCHITECT04P573204P57322026-01-01
00380740213565Alinity09P680209P68022025-12-25
00380740213572Alinity09P690209P69022025-12-25
00380740213558Alinity06U810106U81012025-09-25
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00812101031629ARK™ Ketamine II CalibratorARK DIAGNOSTICS INCDLJ2025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
07613336224830MTX CalibratorRoche Diagnostics GmbHDLJ2024-03-25
00840937103265Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103272Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103289Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00840937103296Immunalysis CorporationIMMUNALYSIS CORPORATIONDLJ2023-10-26
00894354002366Beckman CoulterSALADAX BIOMEDICAL, INC.DLJ2022-06-15
B07604120LZI Tramadol Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604130LZI Tramadol Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604140LZI Tramadol Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07604150LZI Tramadol High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-05-01
B07605220LZI Cotinine II Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605230LZI Cotinine II Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605240LZI Cotinine II Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
B07605250LZI Cotinine II High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2022-04-22
00894354002212MyCare PsychiatrySALADAX BIOMEDICAL, INC.DLJ2022-01-27
00850624008278Fentanyl Qualitative Calibrator SetLIN-ZHI INTERNATIONAL, INC.DLJ2021-10-18
00812101030509ARK™ HS Benzodiazepine II CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030516ARK™ HS Benzodiazepine II Negative CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030523ARK™ HS Benzodiazepine II 100ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
00812101030530ARK™ HS Benzodiazepine II 200ng/mL Cutoff CalibratorARK DIAGNOSTICS INCDLJ2021-08-31
B07606250LZI Oxycodone 300 High CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-19
B07606120LZI Oxycodone 100 Low CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18
B07606130LZI Oxycodone 100 Cutoff CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18
B07606140LZI Oxycodone 100 Intermediate CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2021-08-18