FDA.reportPublic FDA data

PD-L1 (ZR3) Rabbit Monoclonal Antibody

Primary DI
00841683119340
Brand
PD-L1 (ZR3) Rabbit Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
438R-28-ASR
Published
2020-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841683119340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841683119340008416831193408416831193400841683119340

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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08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
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10190302010405Human CD14 TRI-COLOR® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010412Human CD14 Biotin ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010429Human CD14 PE-Texas Red® ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010436Human CD14 PE-Cy®5.5 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010443Human CD14 APC- Alexa Fluor® 750 Conj.LIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
10190302010450Human CD14 Pacific Blue™ ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06
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