FDA.reportPublic FDA data

BD PCR Cartridge

Primary DI
30382904375196
Brand
BD PCR Cartridge
Company
BECTON, DICKINSON AND COMPANY
Model
437519
Catalog number
437519
Device description
BD PCR Cartridges 24EA
Published
2017-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJRNucleic acid amplification assay system, group b streptococcus, direct specimen test
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestMicrobiology1
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111860000BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO2012-02-16NJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904375196PrimaryGS10
00382904375195Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290437519630382904375196
00382904375195003829043751953829043751950382904375195

GMDN Terms#

Term, Definition table
TermDefinition
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
24
Lot or batch
true
Expiration date on label
true

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