FDA.reportPublic FDA data

ADVIA® Chemistry ACET Acetaminophen Reagents

Primary DI
00630414498942
Brand
ADVIA® Chemistry ACET Acetaminophen Reagents
Company
Siemens Healthcare Diagnostics Inc.
Model
10327381
Catalog number
7989138
Device description
Acetaminophen - ADVIA Chem. - RGT - 4x150 tests
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K100200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100200000ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138Siemens Healthcare Diagnostics2010-08-02LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414498942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414498942006304144989426304144989420630414498942

GMDN Terms#

Term, Definition table
TermDefinition
Acetaminophen 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 acetaminophen in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31
00630414293752Atellica IM SHBG11206215112062152020-05-31

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
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
00380740003661ARCHITECTABBOTT LABORATORIESLDP2016-09-09
15099590229962SynchronBeckman Coulter, Inc.LDP2016-08-24
10758750008339VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LDP2016-08-23