FDA.reportPublic FDA data

BOND

Primary DI
05055331335906
Brand
BOND
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0988-U
Catalog number
PA0988-U
Device description
MLH1 (Mismatch Repair Protein) (ES05) is a mouse anti-human monoclonal antibody produced as a 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 7 mL. 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
05055331335906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331335906050553313359065055331335906

GMDN Terms#

Term, Definition table
TermDefinition
MLH1 antigen 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 MLH1 antigen 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
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
08718858481743Kreatech FISH probes23P004C5502022-08-08
08718858481798Kreatech FISH probes04Q001B5502022-08-08
08718858481804Kreatech FISH probes04Q005B5502022-08-08
08718858481811Kreatech FISH probes08C001B4952022-08-08
08718858481880Kreatech FISH probes01P003B5502022-08-08
08718858481958Kreatech FISH probes04C001B4952022-08-08
08718858480029Kreatech FISH probes06Q003B4952022-08-05
08718858480036Kreatech FISH probes10Q001B4952022-08-05
08718858481613Kreatech FISH probes14Q001B5502022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15415219000758Idylla™ MSI TestBiocartis NVPZJ2023-05-03
05055331335920BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336002BONDLEICA BIOSYSTEMS NEWCASTLE LTDPZJ2023-03-03
05055331336019BONDLEICA 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