FDA.report

BRST-2 (GCDFP-15) Monoclonal Antibody, Purified

Primary DI
00810034700230
Brand
BRST-2 (GCDFP-15) Monoclonal Antibody, Purified
Company
BIOLEGEND, INC.
Model
915102
Catalog number
915102
Device description
URL: https://www.biolegend.com/en-us/products/brst-2-gcdfp-15-monoclonal-antibody-purified-10944
Published
2021-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00810034700230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810034700230008100347002308100347002300810034700230

GMDN Terms

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

TypeValueUnit
Total Volume6Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
858-768-5800techserv@biolegend.com

Regulatory Flags

DUNS number
119240658
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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