FDA.report

BOND™

Primary DI
05055331316615
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
AR0633
Catalog number
AR0633
Device description
The Stringency Wash Solution is intended for use with nucleic acid probes to reduce non-specific hybridization in formalin-fixed, paraffin-embedded tissue when performing in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Published
2021-04-09
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
PPMGeneral Purpose Reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055331316615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055331316615050553313166155055331316615

GMDN Terms

TermDefinition
Nucleic acid hybridization detection IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].

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

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05055331337405BONDDS9202-UDS9202-U2025-12-11
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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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