FDA.report

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
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
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810113061375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113061375008101130613758101130613750810113061375

GMDN Terms

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

TypeValueUnit
Total Volume0.1Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
877-772-2622ivdorders@abcam.com

Regulatory Flags

DUNS number
118926596
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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

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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
00810138720127Rabbit Monoclonal Anti-Human ERG (EP111), concentratedAC-0105NBBULK2023-07-31
00810138720134Rabbit Monoclonal Anti-Human BOB.1AC-01142023-07-31
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00810138720219Rabbit Monoclonal Anti-Human PSMA (EP192)AC-0160CMBULK2023-07-31
00810138720226Rabbit Monoclonal Anti-Human PAX2 (EP235)AC-0236CMBULK2023-07-31
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00810138720271Rabbit Monoclonal Anti-Human EGFR L858R (EP344)AC-03172023-07-31
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00810138720301Rabbit Monoclonal Anti-Human CD30 (EP413)AC-0370BULK2023-07-31

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