FDA.reportPublic FDA data

BOND

Primary DI
05055331336019
Brand
BOND
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0991-U
Catalog number
PA0991-U
Device description
PMS2 (Mismatch Repair Protein) (EP51) is a rabbit anti-human monoclonal antibody produced as an affinity purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800).
Published
2023-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZJLynch Syndrome Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZJLynch Syndrome Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213348000BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.2023-02-21PZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055331336019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331336019050553313360195055331336019

GMDN Terms#

Term, Definition table
TermDefinition
Postmeiotic segregation increased 2 (PMS2) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of postmeiotic segregation increased 2 (PMS2), a DNA mismatch repair protein, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags#

DUNS number
397134693
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055331334725BOND™PA0258-UPA0258-U2022-12-16
05055331315229Novocastra™CBE-356-L-CENCL-L-CBE-3562022-12-07
05055331302038Novocastra™RE7120-CERE7120-K2021-05-17
05055331311788Novocastra™CK20-561-L-CENCL-L-CK20-5612021-04-23
05055331304407BOND™PA0258PA02582021-04-16
05055331321206Novocastra™MSA-L-UNCL-L-MSA2021-04-16
05055331303752BOND™PA0934PA09342021-04-09
05055331303783BOND™PA0906PA09062021-03-12
05055331330581BOND-PRIMECS9300CS93002026-07-08
05055331339607BONDPA0678-UPA0678-U2026-04-10
05055331316967Novocastra™AE1/AE3-L-CENCL-L-AE1/AE32022-12-07
08718858480791Kreatech FISH probes22Q003B4952022-09-21
08718858481231Kreatech FISH probes02P009V5502022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V4952022-09-21
08718858481668Kreatech FISH probes03Q001B5502022-08-08
08718858481675Kreatech FISH probes03Q002B4952022-08-08
08718858481712Kreatech FISH probes13Q002C4952022-08-08
08718858481729Kreatech FISH probes14Q001C4152022-08-08
08718858481736Kreatech FISH probes16Q001B4952022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15415219000758Idylla™ MSI TestBiocartis NVPZJ2023-05-03
05055331335906BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331335920BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336002BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
00849811056857OncoMate MSI Dx Interpretive SoftwarePROMEGA CORPORATIONPZJ2021-10-08
00849811056864OncoMate MSI Dx Assay InstallerPROMEGA CORPORATIONPZJ2021-10-08
00849811031717OncoMate MSI Dx Analysis SystemPROMEGA CORPORATIONPZJ2021-09-30
00849811050619OncoMate 5C Matrix StandardPROMEGA CORPORATIONPZJ2021-09-30
07613336100561VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100578VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100585VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100592VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08
07613336100608VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical Systems, Inc.PZJ2018-02-08