Access PCT

Primary DI
15099590719531
Brand
Access PCT
Company
IMMUNOTECH
Model
C53987
Catalog number
C53987
Device description
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
Published
2020-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu AdmissionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590719531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959071953115099590719531

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
270264732
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590795443CD25-SNv650C97990C979902025-10-01
15099590795450CD33-SNv650C97991C979912025-10-01
15099590795467CD56-SNv650C97992C979922025-10-01
15099590795474CD7-SNv650C97993C979932025-10-01
15099590795481CD14-SNv650C97994C979942025-10-01
15099590795498CD20-SNv650D05546D055462025-10-01
15099590796228CD8-SNv786D17894D178942025-10-01
15099590796235CD23-SNv786D17895D178952025-10-01
15099590796242CD7-SNv786D17896D178962025-10-01
15099590796266CD4-SNv605D17898D178982025-10-01
15099590796273CD22-SNv605D17900D179002025-10-01
15099590748098BeckmancoulterC76796C767962025-03-05
15099590748128BeckmancoulterC76799C767992025-03-05
15099590748159BeckmancoulterC76802C768022025-03-05
15099590748180BeckmancoulterC76805C768052025-03-05
15099590748210BeckmancoulterC76808C768082025-03-05
15099590748241BeckmancoulterC76811C768112025-03-05
15099590748272BeckmancoulterC76814C768142025-03-05
15099590748302BeckmancoulterC76817C768172025-03-05
15099590748333BeckmancoulterC76820C768202025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04051839013668DiaSys Procalcitonin FSDiaSys Diagnostic Systems GmbHPTF2025-08-01
15099590736002Access PCTBeckman Coulter, Inc.PTF2023-05-05
00380740153953AlinityAbbott Ireland DiagnosticsPTF2019-01-04
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PTF2018-10-05
00380740138905ARCHITECTAbbott GmbHPTF2017-08-16
00380740138912ARCHITECTAbbott GmbHPTF2017-08-16
00380740139032ARCHITECTAbbott GmbHPTF2017-08-16
00380740139049ARCHITECTAbbott GmbHPTF2017-08-16
00657498001950Procalcitonin LiquiColorSTANBIO LABORATORY, L.P.PTF2017-06-26
00657498001967Procalcitonin (PCT) CalibratorsSTANBIO LABORATORY, L.P.PTF2017-06-26
00657498001974Procalcitonin (PCT) Bi-Level ControlsSTANBIO LABORATORY, L.P.PTF2017-06-26