FDA.reportPublic FDA data

BD Viper™ LT System

Primary DI
00382904428396
Brand
BD Viper™ LT System
Company
BECTON, DICKINSON AND COMPANY
Model
442839
Catalog number
442839
Device description
Instrument Bd Viper LT System
Published
2016-05-19
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
OOIreal time Nucleic acid amplification system

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140447000BD VIPER LT SYSTEMBecton, Dickinson and Company2014-05-20OOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904428396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904428396003829044283963829044283960382904428396

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth36Inch
Height46Inch
Width51Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius33 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Serial number
true

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