FDA.report

BOND™

Primary DI
05055331336729
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0988-X
Catalog number
PA0988-X
Device description
MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MutL homolog 1 (MLH1) protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX and BOND-III systems). The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055331336729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055331336729050553313367295055331336729

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags

DUNS number
397134693
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05055331337405BONDDS9202-UDS9202-U2025-12-11
05055331304087BOND™PA0449PA04492021-05-28
05055331336903BONDPA0240-UPA0240-U2025-01-31
05055331337504BOND-PRIMEDS9397DS93972024-06-11
05055331336323BONDPA0756-UPA0756-U2024-03-01
05055331336330BONDPA0713-UPA0713-U2024-03-01
05055331336354BONDPA0101-UPA0101-U2024-03-01
05055331336361BONDPA0310-UPA0310-U2024-03-01
05055331336378BONDPA0347-UPA0347-U2024-03-01
05055331336804BONDPA0977-UPA0977-U2024-03-01
05055331337009BONDPA0866-UPA0866-U2024-03-01
05055331324078NovocastraCD146-L-UNCL-L-CD1462024-01-31
05055331336385BONDPA0010-UPA0010-U2024-01-19
05055331336392BONDPA0030-UPA0030-U2024-01-19
05055331300171NovocastraVWF-L-UNCL-L-VWF-U2023-07-28
05055331320704NovocastraCD163-L-UNCL-L-CD163-U2023-07-28
05055331320803NovocastraCK17-L-UNCL-L-CK17-U2023-07-28
05055331321107NovocastraP57-L-UNCL-L-P57-U2023-07-28
05055331321138NovocastraCD16-L-UNCL-L-CD16-U2023-07-28
05055331321374NovocastraCD13-304-L-UNCL-L-CD13-304-U2023-07-28

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