FDA.report

SAE Admin Console Dx Software V1.1.0 Kit

Primary DI
10190302017312
Brand
SAE Admin Console Dx Software V1.1.0 Kit
Company
LIFE TECHNOLOGIES CORPORATION
Model
A52570, V1.1.0
Published
2022-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OOIreal time Nucleic acid amplification system

Product Code Classifications

CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190302017312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019030201731210190302017312

GMDN Terms

TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Sterilization Methods

Method

Regulatory Flags

DUNS number
080131636
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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