FDA.reportPublic FDA data

GeneXpert Infinity-48s System

Primary DI
07332940004354
Brand
GeneXpert Infinity-48s System
Company
CEPHEID
Model
INFINITY48-16
Catalog number
900-0536
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332940004354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332940004354073329400043547332940004354

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-30 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888383222techsupport@cepheid.com

Regulatory Flags#

DUNS number
956711444
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07332940009687GeneXpert®GeneXpert XVI (GX-XVI)2025-08-15
07332940009366GeneXpert®GXHCV-10 GXHCV-10 2024-07-22
07332940008161GeneXpert®XPRSGBS-10XPRSGBS-102024-02-16
07332940008581GeneXpert®XPRS-COV2-10XPRS-COV2-102024-01-22
07332940009243GeneXpert® XpressGX-IV XpressGX-IV Xpress2023-10-20
07332940008604GeneXpert®XPRS4PLEX-10XPRS4PLEX-102023-09-25
07332940007652Xpert®GXGBSLBXCGXGBSLBXC-102022-07-29
07332940007669Xpert®GXGBSLBXCGXGBSLBXC-1202022-07-29
07332940007195GeneXpert®GXIV-HUB900-08282022-05-12
07332940006457Xpert®SWAB/F-100SWAB/F-1002022-05-03
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
07332940007072Xpert®XPRSMVP-10XPRSMVP-102022-04-13
07332940008345Xpert®SWAB/G-50-USSWAB/G-50-US2022-04-12

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