FDA.reportPublic FDA data

Keratin 5 Polyclonal Antibody, Purified

Primary DI
00810034700063
Brand
Keratin 5 Polyclonal Antibody, Purified
Company
BIOLEGEND, INC.
Model
905501
Catalog number
905501
Device description
URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-antibody-purified-10956
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810034700063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034700063008100347000638100347000630810034700063

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00If thawed and stored between 2°C and 8°C, product is stable for 24 months from the date of thaw or until the expiry date on the label, whichever comes first.
Special Storage Condition, Specify00When stored at or below -20°C, product is stable until the date shown on the label. Avoid repeated freeze-thaw cycles to prevent denaturing the antibody.
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-768-5800techserv@biolegend.com

Regulatory Flags#

DUNS number
119240658
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00810034704061PE/Dazzle™ 594 anti-human CD229876069876062026-06-01
00810034704092FITC anti-human CD359899289899282026-06-01
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00810034704016FITC anti-human TdT9899189899182025-12-22
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00810034704054Spark Violet™ 538 anti-human HLA-DR9804249804242025-12-22
00810034703989Spark Red™ 718 anti-human CD19 9824229824222025-12-12

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