FDA.reportPublic FDA data

Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3

Primary DI
00810113061375
Brand
Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3
Company
Epitomics Inc.
Model
AC-0014A
Device description
Rabbit Monoclonal Anti-Human HER2/ErbB2 (3), 0.1 mL concentrated
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113061375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113061375008101130613758101130613750810113061375

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein 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 c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-772-2622ivdorders@abcam.com

Regulatory Flags#

DUNS number
118926596
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113064925Rabbit Monoclonal Anti-Human Aurora B Antibody, EP136AC-0196A2023-06-13
00810113064932Rabbit Monoclonal Anti-Human Aurora B Antibody, EP136AC-0196B2023-06-13
00810113064949Rabbit Monoclonal Anti-Human Aurora B Antibody, EP136AC-01962023-06-13
00810113064956Rabbit Monoclonal Anti-Human Aurora B Antibody, EP136AC-0196BULK2023-06-13
00810113061368Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3AC-0014BULK2023-06-08
00810113061382Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3AC-0014B2023-06-08
00810113061399Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3AC-00142023-06-08
00810113066622Rabbit Monoclonal Anti-Human Histone H3 Phospho (pT3) Antibody, EP233AC-0250BULK2023-06-16
00810113066639Rabbit Monoclonal Anti-Human Histone H3 Phospho (pT3) Antibody, EP233AC-0250A2023-06-16
00810113066646Rabbit Monoclonal Anti-Human Histone H3 Phospho (pT3) Antibody, EP233AC-0250B2023-06-16
00810113066653Rabbit Monoclonal Anti-Human Histone H3 Phospho (pT3) Antibody, EP233AC-02502023-06-13
00810113067346Rabbit Monoclonal Anti-Human CDX-2 (EP25), concentratedAC-0008CMBULK2023-07-31
00810113068985Rabbit Monoclonal Anti-Human Cytokeratin 20 (EP23), concentratedAC-0026BULK2023-07-31
00810138720059Rabbit Monoclonal Anti-Human Cytokeratin 18 (EP30)AC-0001BULK2023-07-31
00810138720066Rabbit Monoclonal Anti-Human GFAP (EP13), concentratedAC-0002BULK2023-07-31
00810138720073Rabbit Monoclonal Anti-Human GFAP (EP13), concentratedAC-0002CMBULK2023-07-31
00810138720080Rabbit Monoclonal Anti-Human E-Cadherin (EP6) AC-0003BULK2023-07-31
00810138720097Rabbit Monoclonal Anti-Human E-Cadherin (EP6) AC-0003CMBULK2023-07-31
00810138720103Rabbit Monoclonal Anti-Human Androgen Rector (EP120), concentratedAC-0071CMBULK2023-07-31
00810138720110Rabbit Monoclonal Anti-Human GCDFP-15 (EP95)AC-0085CMBULK2023-07-31

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