FDA.reportPublic FDA data

CD45RO (UCHL-1) Mouse Monoclonal Antibody

Primary DI
00841683125075
Brand
CD45RO (UCHL-1) Mouse Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
147M-97
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00841683125075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841683125075008416831250758416831250750841683125075

GMDN Terms#

Term, Definition table
TermDefinition
CD45 leukocyte common antigen 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 CD45 leukocyte common antigen 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

Regulatory Flags#

DUNS number
025048773
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841683100102CD57 (NK-1) Mouse Monoclonal Antibody760-26262025-06-27
00841683100324Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody760-26712025-06-27
00841683100430Inhibin, alpha (R1) Mouse Monoclonal Antibody760-28342025-06-27
00841683106746CD57 (NK-1) Mouse Monoclonal Antibody760-26262021-04-15
00841683109761Thyroglobulin (2H11+6E1) Mouse Monoclonal Antibody760-26712021-04-15
00841683110842Inhibin, alpha (R1) Mouse Monoclonal Antibody760-28342020-09-15
00841683104377INSM1 (MRQ-70) Rabbit Monoclonal Antibody475R-942020-12-14
00841683107521INSM1 (MRQ-70) Rabbit Monoclonal Antibody475R-952020-12-14
00841683107668INSM1 (MRQ-70) Rabbit Monoclonal Antibody475R-962020-12-14
00841683107699INSM1 (MRQ-70) Rabbit Monoclonal Antibody475R-972020-12-14
00841683108030INSM1 (MRQ-70) Rabbit Monoclonal Antibody475R-982020-12-14
00841683110637MDM2 (IF2) Mouse Monoclonal Antibody479M-962020-12-14
00841683113096MDM2 (IF2) Mouse Monoclonal Antibody479M-952020-12-14
00841683114390CDK4 (DCS-31) Mouse Monoclonal Antibody478M-942020-12-14
00841683115250CDK4 (DCS-31) Mouse Monoclonal Antibody478M-982020-12-14
00841683117179MDM2 (IF2) Mouse Monoclonal Antibody479M-942020-12-14
00841683117933CDK4 (DCS-31) Mouse Monoclonal Antibody478M-972020-12-14
00841683118534MDM2 (IF2) Mouse Monoclonal Antibody479M-982020-12-14
00841683118732CDK4 (DCS-31) Mouse Monoclonal Antibody478M-952020-12-14
00841683118749CDK4 (DCS-31) Mouse Monoclonal Antibody478M-962020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336182765VENTANA pan-TRK (EPR17341) AssayVentana Medical Systems, Inc.NJT2026-03-16
00847627042637Pan TRK [RM423]BIOCARE MEDICAL LLCNJT2026-02-19
07613336231395PAX-8 (SP348) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-02-16
00847627042279CK7BIOCARE MEDICAL LLCNJT2026-01-29
00847627042033DesminBIOCARE MEDICAL LLCNJT2026-01-13
00847627042835CD19BIOCARE MEDICAL LLCNJT2026-01-13
00847627041937Myeloperoxidase (P)BIOCARE MEDICAL LLCNJT2026-01-06
00847627042514VimentinBIOCARE MEDICAL LLCNJT2026-01-06
00615233011435Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233011442Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233013996Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014009Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014474Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014481Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014559Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014566Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00847627042019CD43BIOCARE MEDICAL LLCNJT2025-12-16
00847627042118Cytokeratin 18 (CK18)BIOCARE MEDICAL LLCNJT2025-12-16
00847627042491CD79aBIOCARE MEDICAL LLCNJT2025-12-16
00847627042576Cytokeratin [AE1] LMWBIOCARE MEDICAL LLCNJT2025-12-16
00847627042897CD103 (RM)BIOCARE MEDICAL LLCNJT2025-12-16
04015630971176Bluing ReagentVentana Medical Systems, Inc.NJT2025-12-15
04015630971299Amplification KitVentana Medical Systems, Inc.NJT2025-12-15
04015630972128CONFIRM anti-ALK1 (ALK01) Primary AntibodyVentana Medical Systems, Inc.NJT2025-12-15
07613336158357VENTANA Red ISH DIG Detection KitVentana Medical Systems, Inc.NJT2025-12-15
07613336158418VENTANA Silver ISH DNP Detection KitVentana Medical Systems, Inc.NJT2025-12-15
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNJT2025-11-25
00847627042132CD7BIOCARE MEDICAL LLCNJT2025-11-25
00847627042965Pan Melanoma Cocktail-2BIOCARE MEDICAL LLCNJT2025-11-17
00847627039095Desmoglein 3BIOCARE MEDICAL LLCNJT2025-09-19