FDA.reportPublic FDA data

SmartCycler Dx System

Primary DI
07332940004767
Brand
SmartCycler Dx System
Company
CEPHEID
Model
SC2500N5-1
Catalog number
SC2500N5-1
Device description
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
Published
2018-07-03
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
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062948000SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7BCepheid2006-12-08NJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940004767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940004767073329400047677332940004767

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification, and operates with minimal technician input and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888383222techsupport@cepheid.com

Regulatory Flags#

DUNS number
956711444
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332940009489XpertGXGI-10GXGI-102026-01-30
07332940009694GeneXpert®GX-IV R22026-01-19
07332940009700GeneXpert® XpressGX-IV Xpress2026-01-19
07332940007072Xpert®XPRSMVP-10XPRSMVP-102022-04-13
07332940000196Xpert MRSAGXMRSA-100N-10GXMRSA-100N-102018-01-29
07332940000240Xpert Factor II & Factor VGXFIIFV-10GXFIIFV-102018-01-29
07332940001711Xpert MRSA NxGGXMRSA-NXG-10GXMRSA-NXG-102018-01-29
07332940001728Xpert MRSA NxGGXMRSA-NXG-120GXMRSA-NXG-1202018-01-29
07332940002442Xpert MRSAGXMRSA-120GXMRSA-1202018-01-29
07332940009519GeneXpert® GXFIIFV-US-10GXFIIFV-US-102025-11-21
07332940009687GeneXpert®GeneXpert XVI (GX-XVI)2025-08-15
07332940008161GeneXpert®XPRSGBS-10XPRSGBS-102024-02-16
07332940009243GeneXpert® XpressGX-IV XpressGX-IV Xpress2023-10-20
07332940007195GeneXpert®GXIV-HUB900-08282022-05-12
07332940007683GeneXpert®GX-II R2GX-II R22022-05-03
07332940007690GeneXpert®GX-IV R2GX-IV R22022-05-03
07332940007706GeneXpert®GX-XVI R2GX-XVI R22022-05-03
07332940007713GeneXpert®GX-INFINITY 48SGX-INFINITY 48S2022-05-03
07332940007720GeneXpert®GX-INFINITY 80GX-INFINITY 802022-05-03
07332940000974Xpert NorovirusGXNOV-10GXNOV-102018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332940008161GeneXpert®CEPHEIDNJR2024-02-16
06974849369243Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369250Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369267Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369274Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
06974849369281Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPJiangsu Macro & Micro-Test Med-Tech Co., Ltd.NJR2022-12-06
07332940007652Xpert®CEPHEIDNJR2022-07-29
07332940007669Xpert®CEPHEIDNJR2022-07-29
07332940007683GeneXpert®CEPHEIDNJR2022-05-03
07332940007690GeneXpert®CEPHEIDNJR2022-05-03
00840733102363Revogene GBS LBMERIDIAN BIOSCIENCE, INC.NJR2020-07-15
00628055344117Revogene® GBS LBMeridian Bioscience Canada IncNJR2019-10-21
15420045510470Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510890Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510463Panther Fusion®Hologic, Inc.NJR2019-07-30
15420045510906Panther Fusion®Hologic, Inc.NJR2019-07-30
10814278020045NeuMoDxTM GBS Test StripNeumodx Molecular, Inc.NJR2019-04-03
30014613336440SolanaDIAGNOSTIC HYBRIDS, INC.NJR2019-03-21
00840733102110Alethia™ Group B Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
00840733102196Alethia™ Group B StreptococcusMERIDIAN BIOSCIENCE, INC.NJR2019-01-08
20816101025644Simplexa™ GBS DirectDIASORIN MOLECULAR LLCNJR2018-11-20
20816101025651Simplexa™ GBS Positive Control PackDIASORIN MOLECULAR LLCNJR2018-11-20
30014613312024AmpliVueQUIDEL CORPORATIONNJR2018-08-30
07332940004521SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004538SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004545SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004569SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004583SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004606SmartCycler Dx SystemCEPHEIDNJR2018-07-03
07332940004880SmartCycler Dx SystemCEPHEIDNJR2018-07-03