FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740003661
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
2K99-01
Catalog number
02K9901
Device description
Acetaminophen Calibrator
Published
2016-09-09
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
LDPCOLORIMETRY, ACETAMINOPHEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDPColorimetry, AcetaminophenClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042330000ACETAMINOPHEN-SL ASSAYDiagnostic Chemicals , Ltd.2005-01-07LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740003661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740003661003807400036613807400036610380740003661

GMDN Terms#

Term, Definition table
TermDefinition
Acetaminophen IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of acetaminophen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do not freeze.
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
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
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654164Atellica CH Acetaminophen (AcetC)Siemens Healthcare Diagnostics Inc.LDP2025-10-15
00628063401314Alinity c AcetaminophenSEKISUI DIAGNOSTICS, LLCLDP2023-05-08
07613336120934ONLINE TDM Acetaminophen Gen.2Roche Diagnostics GmbHLDP2020-03-05
00628063401185Acetaminophen AssaySEKISUI DIAGNOSTICS, LLCLDP2019-10-02
00628063401215Acetaminophen L3K AssaySEKISUI DIAGNOSTICS, LLCLDP2019-10-02
30014613337867TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
30014613337904TriageQUIDEL CARDIOVASCULAR INC.LDP2018-11-01
00630414595894Atellica CH AcetSiemens Healthcare Diagnostics Inc.LDP2017-12-22
00842768001550Syva® Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768005787Dimension® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768015014Dimension Vista® Flex® reagent cartridge ACTMSiemens Healthcare Diagnostics Inc.LDP2016-09-24
00842768023330Emit® tox™ Acetaminophen AssaySiemens Healthcare Diagnostics Inc.LDP2016-09-24
00884883001169DRI Acetaminophen Serum Tox AssayMicrogenics CorporationLDP2016-09-24
00884883001176DRI Acetaminophen Serum Tox CalibratorsMicrogenics CorporationLDP2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen ReagentsSiemens Healthcare Diagnostics Inc.LDP2016-09-24
04015630981205AcetaminophenRoche Diagnostics GmbHLDP2016-09-23
00657498000427Acetaminophen Liquicolor®STANBIO LABORATORY, L.P.LDP2016-09-23
00899722002757Alere Triage®Alere San Diego, Inc.LDP2016-09-21
04015630935031ONLINE TDM Acetaminophen Gen2Roche Diagnostics GmbHLDP2016-09-20
04015630946372AcetaminophenRoche Diagnostics GmbHLDP2016-09-20
00628063400027ACETAMINOPHEN L3KSEKISUI DIAGNOSTICS, LLCLDP2016-09-20
00893038002135Alere Triage®Alere San Diego, Inc.LDP2016-09-19
00628063400034ACETAMINOPHEN L3KSEKISUI DIAGNOSTICS, LLCLDP2016-09-16
05055273208139ACERANDOX LABORATORIES LIMITEDLDP2016-09-09
15099590229962SynchronBeckman Coulter, Inc.LDP2016-08-24
10758750008339VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LDP2016-08-23