BD MAX Check-Points CPO

Primary DI
00180002781029
Brand
BD MAX Check-Points CPO
Company
Check-Points Health B.V.
Model
278102
Catalog number
278102
Device description
BD MAX Check-Points CPO contains: 24 each, Master Mix, Reagent Strips, Extraction Tubes, Sample Buffer Tubes, Septum Caps. The BD MAX Check-Points CPO Assay detects the presence of carbapenemase genes in Gram-negative bacteria and includes an internal Sample Processing Control.
Published
2019-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00180002781029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00180002781029001800027810291800027810290180002781029

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antimicrobial resistance nucleic acid IVD, 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

Regulatory Flags#

DUNS number
409613986
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904452629BD MAX™ CPOBECTON, DICKINSON AND COMPANYPOC2023-10-06
07332940001032Xpert Carba-RCEPHEIDPOC2018-01-29