FDA.reportPublic FDA data

MSH6 (44) Mouse Monoclonal Antibody

Primary DI
00841683111474
Brand
MSH6 (44) Mouse Monoclonal Antibody
Company
CELL MARQUE CORPORATION
Model
287M-14-ASR
Published
2020-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00841683111474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841683111474008416831114748416831114740841683111474

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04065269246220H3 K36M (RM193) Rabbit Monoclonal Antibody495R-142025-03-21
04065269246244H3 K36M (RM193) Rabbit Monoclonal Antibody495R-152025-03-21
04065269246251H3 K36M (RM193) Rabbit Monoclonal Antibody495R-162025-03-21
04065269246275H3 K36M (RM193) Rabbit Monoclonal Antibody495R-172025-03-21
04065269246299H3 K36M (RM193) Rabbit Monoclonal Antibody495R-182025-03-21
04065270971531Pit-1 (ZM385) Mouse Monoclonal Antibody496M-142025-03-21
04065270971555Pit-1 (ZM385) Mouse Monoclonal Antibody496M-152025-03-21
04065270971562Pit-1 (ZM385) Mouse Monoclonal Antibody496M-162025-03-21
04065270971586Pit-1 (ZM385) Mouse Monoclonal Antibody496M-172025-03-21
04065270971609Pit-1 (ZM385) Mouse Monoclonal Antibody496M-182025-03-21
04065270976963H3.3 G34W (RM263) Rabbit Monoclonal Antibody493R-142025-03-21
04065270976994H3.3 G34W (RM263) Rabbit Monoclonal Antibody493R-152025-03-21
04065270978714H3.3 G34W (RM263) Rabbit Monoclonal Antibody493R-162025-03-21
04065270978745H3.3 G34W (RM263) Rabbit Monoclonal Antibody493R-172025-03-21
04065270978776H3.3 G34W (RM263) Rabbit Monoclonal Antibody493R-182025-03-21
04065270313997NUTM1 (C52B1) Rabbit Monoclonal Antibody494R-142025-03-03
04065270317612NUTM1 (C52B1) Rabbit Monoclonal Antibody494R-152025-03-03

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Primary DI, Brand, Company table
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03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
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