FDA.reportPublic FDA data

ACE

Primary DI
05055273208139
Brand
ACE
Company
RANDOX LABORATORIES LIMITED
Model
ACE4023
Catalog number
ACE4023
Device description
The paracetamol test system is intended for the quantitative in vitro determination of Acetaminophen in human serum.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K880829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880829000GDS ENZYMATIC ACETAMINOPHEN REAGENTGds Technology, LLC1988-05-27LDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273208139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208139050552732081395055273208139

GMDN Terms#

Term, Definition table
TermDefinition
Acetaminophen IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of acetaminophen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze. Stable on board analyser for 7 days at approx 10 DegC
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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