FDA.reportPublic FDA data

Rabbit Monoclonal Anti-Human STAT6, EP325

Primary DI
00810113068527
Brand
Rabbit Monoclonal Anti-Human STAT6, EP325
Company
Epitomics Inc.
Model
AC-0318
Device description
Rabbit Monoclonal Anti-Human STAT6 (325), 1 mL concentrated
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810113068527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113068527008101130685278101130685270810113068527

GMDN Terms#

Term, Definition table
TermDefinition
Signal transducer and activator of transcription (STAT) protein 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 a signal transducer and activator of transcription (STAT) protein [e.g., STAT6] in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

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
00810113061375Rabbit Monoclonal Anti-Human HER2 / ErbB2 Antibody, EP3AC-0014A2023-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-05-18
00847627051622CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00846405000005Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000012Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000029Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00847627040664SALL4BIOCARE MEDICAL LLCNJT2026-04-01
00847627041036Cyclin D1BIOCARE MEDICAL LLCNJT2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})BIOCARE MEDICAL LLCNJT2026-04-01
00847627042194Caspase-3 (Cleaved)BIOCARE MEDICAL LLCNJT2026-04-01
00847627042590S100PBIOCARE MEDICAL LLCNJT2026-04-01
00847627042859CD33BIOCARE MEDICAL LLCNJT2026-04-01
07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.NJT2026-03-26
00847627041500Uroplakin II + Uroplakin IIIBIOCARE MEDICAL LLCNJT2025-11-19
00847627041845SOX11 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042156CDH17 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042552Epithelial Membrane Antigen (EMA) [E29] BIOCARE MEDICAL LLCNJT2025-11-19
00847627042675CDX2 (RM)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042736IgG4 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627040640p53BIOCARE MEDICAL LLCNJT2025-11-10
00847627041975DOG1BIOCARE MEDICAL LLCNJT2025-11-10
00847627042811CD19 (RM) [RM332]BIOCARE MEDICAL LLCNJT2025-10-31
00847627041562Glutamine SynthetaseBIOCARE MEDICAL LLCNJT2025-10-23
00847627041609Cytokeratin 17 (CK17)BIOCARE MEDICAL LLCNJT2025-10-23
07613336234365VENTANA HER2 (CAL27) AssayVentana Medical Systems, Inc.NJT2025-10-21
00847627041821Lambda Light Chain [N10/2]BIOCARE MEDICAL LLCNJT2025-10-21
00847627041883Cytokeratin 5 (CK5)BIOCARE MEDICAL LLCNJT2025-10-21
07613336234433TRPS1 (SP532) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2025-10-16
00847627040008HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10
00847627040015HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10