FDA.report

Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3

Primary DI
00810113061382
Brand
Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3
Company
Epitomics Inc.
Model
AC-0014B
Device description
Rabbit Monoclonal Anti-Human HER2/ErbB2 (3), 0.5 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
00810113061382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113061382008101130613828101130613820810113061382

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 Volume0.5Milliliter

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

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00810138720066Rabbit Monoclonal Anti-Human GFAP (EP13), concentratedAC-0002BULK2023-07-31
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