FDA.reportPublic FDA data

CD57 (NK-1) Mouse Monoclonal Antibody

Primary DI
00841683106746
Brand
CD57 (NK-1) Mouse Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
760-2626
Published
2021-04-15
Public version status
Update
Distribution status
Not 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
00841683106746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841683106746008416831067468416831067460841683106746

GMDN Terms#

Term, Definition table
TermDefinition
CD57 natural killer 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 CD57 natural killer 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
Manufacturing date on label
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
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
00841683128717MDM2 (IF2) Mouse Monoclonal Antibody479M-972020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000036Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000227Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000234Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000241Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000319Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000326Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000333Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000371Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000388Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000395Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000463Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000470Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000487Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000524Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000531Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000548Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000616Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000623Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000630Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000913Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000920Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000937Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000975Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000982Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000999Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001002Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001019Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001026Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001279Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001286Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08