FDA.report

BOND™

Primary DI
05055331303776
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0909
Catalog number
PA0909
Device description
Multi-Cytokeratin (AE1/AE3) antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kD of the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Published
2021-04-16
Public version status
New
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
05055331303776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055331303776050553313037765055331303776

GMDN Terms

TermDefinition
Cytokeratin 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 one or multiple cytokeratin subtype(s) 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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