FDA.reportPublic FDA data

ROS1 (MRQ-68) Rabbit Monoclonal Antibody

Primary DI
00841683103813
Brand
ROS1 (MRQ-68) Rabbit Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
469R-95-ASR
Published
2020-09-04
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
MVUReagents, Specific, Analyte

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841683103813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841683103813008416831038138416831038130841683103813

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
00841683151340Arginase-1 SP156 Rab.PA07912026-09-04
00841683151364CD163 MRQ-26 Mab.PA07942026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.PA07952026-09-04
00841683151388Ep-CAM MOC31 Mab.PA07972026-09-04
00841683151395GATA3 L50-823 Mab.PA07982026-09-04
00841683151401Glypican-3 1G12 Mab.PA08002026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.PA08012026-09-04
00841683151425IgG4 MRQ-44 Mab.PA08182026-09-04
00841683151432Mammaglobin 31A5 Rab.PA08022026-09-04
00841683151449Microphthalmia Transcription Factor (MiTF) C5/D5 Mab.PA08032026-09-04
00841683151463Napsin A MRQ-60 Mab.PA08052026-09-04
00841683151470p120 Catenin MRQ-5 Mab.PA08062026-09-04
00841683151487PAX8 MRQ-50 Mab.PA08082026-09-04
00841683151494PHH3 PolyclonalPA08172026-09-04
00841683151517Podoplanin D2-40 Mab.PA07962026-09-04
00841683151524Renal Cell Carcinoma PN-15 Mab.PA08112026-09-04
00841683151531S100 Protein 4C4.9 Mab.PA08202026-09-04
00841683151548SOX-10 PolyclonalPA08132026-09-04
00841683151555SOX-11 MRQ-58 Mab.PA08162026-09-04
00841683151562SOX-2 SP76 Rab.PA08152026-09-04

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Primary DI, Brand, Company table
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03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
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