FDA.reportPublic FDA data

BD MAX™ CPO

Primary DI
00382904452629
Brand
BD MAX™ CPO
Company
BECTON, DICKINSON AND COMPANY
Model
445262
Catalog number
445262
Device description
Kit BD MAX CPO
Published
2023-10-06
Public version status
New
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
OOIreal time Nucleic acid amplification system
POCSystem, nucleic acid amplification test, DNA, antimicrobial resistance marker, direct specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2
POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct SpecimenMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190613000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190613000BD MAX Check-Points CPOCheck-Points Health B.V.2019-08-29POC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904452629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904452629003829044526293829044526290382904452629

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antimicrobial resistance 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 multiple genes conferring resistance to multiple antimicrobial drugs in multiple types of bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Genes detected may include, but are not limited to, carbapenemase genes (KPC, NDM, VIM, and OXA), extended spectrum beta-lactamase (ESBL)-encoding genes (e.g., TEM, SHV, IMP, NDM-1 and CTX-M) and/or vancomycin resistance genes (vanA and vanB).

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
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
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00382904003739BD Whitacre Spinal4003734003732023-09-02
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30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30

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