FDA.reportPublic FDA data

BD ProbeTec™ ET Instrument, Remanufactured

Primary DI
00382904407162
Brand
BD ProbeTec™ ET Instrument, Remanufactured
Company
BECTON, DICKINSON AND COMPANY
Model
440716
Catalog number
440716
Device description
BD ProbeTec™ ET Instrument, Remanufactured
Published
2016-05-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984631000BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYBecton Dickinson Microbiology Systems1999-11-04LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904407162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904407162003829044071623829044071620382904407162

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
Depth28.5Inch
Height21.5Inch
Width28.5Inch

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
Lot or batch
true
Serial number
true
Expiration date on label
true

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