FDA.reportPublic FDA data

L1 (Cytoactiv) Mouse Monoclonal Antibody

Primary DI
04065270915078
Brand
L1 (Cytoactiv) Mouse Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
498M-17-ASR
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065270915078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065270915078040652709150784065270915078

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

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

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Primary DI, Brand, Company table
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