FDA.reportPublic FDA data

Rabbit Monoclonal Anti-Human CD99 Antibody, EP8

Primary DI
00810113060439
Brand
Rabbit Monoclonal Anti-Human CD99 Antibody, EP8
Company
Epitomics Inc.
Model
AC-0013BULK
Device description
Rabbit Monoclonal Anti-Human CD99 (8) , 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

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
00810113060439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113060439008101130604398101130604390810113060439

GMDN Terms#

Term, Definition table
TermDefinition
CD99 cell marker 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 CD99 cell marker in a clinical specimen.

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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810138720127Rabbit Monoclonal Anti-Human ERG (EP111), concentratedAC-0105NBBULK2023-07-31
00810138720134Rabbit Monoclonal Anti-Human BOB.1AC-01142023-07-31
00810138720141Rabbit Monoclonal Anti-Human BOB.1AC-0114A2023-07-31
00810138720158Rabbit Monoclonal Anti-Human BOB.1AC-0114B2023-07-31
00810138720165Rabbit Monoclonal Anti-Human BOB.1AC-0114BULK2023-07-31
00810138720219Rabbit Monoclonal Anti-Human PSMA (EP192)AC-0160CMBULK2023-07-31
00810138720226Rabbit Monoclonal Anti-Human PAX2 (EP235)AC-0236CMBULK2023-07-31
00810138720233Rabbit Monoclonal Anti-Human SOX10 (EP268)AC-0237CMBULK2023-07-31
00810138720271Rabbit Monoclonal Anti-Human EGFR L858R (EP344)AC-03172023-07-31
00810138720295Rabbit Monoclonal Anti-Human MAGEC2 (CT10) (EP405)AC-0356CMBULK2023-07-31
00810138720301Rabbit Monoclonal Anti-Human CD30 (EP413)AC-0370BULK2023-07-31

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