FDA.reportPublic FDA data

MetaSystems Probes

Primary DI
04251315818545
Brand
MetaSystems Probes
Company
MetaSystems Probes GmbH
Model
D-5108-100-OG
Catalog number
D-5108-100-OG
Device description
XL t(4;14) FGFR3/IGH DF, Translocation/Dual Fusion Probe
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04251315818545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251315818545042513158185454251315818545

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313215719
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
04251315801264MetaSystems ProbesD-5139-999-OGD-5139-999-OG2026-04-08
04251315801271MetaSystems ProbesD-5141-999-OGD-5141-999-OG2026-04-08
04251315801189MetaSystems ProbesD-0816-050-FID-0816-050-FI2026-03-27
04251315801257MetaSystems ProbesD-0816-050-ORD-0816-050-OR2026-03-27
04251315821057MetaSystems ProbesD-0816-050-FID-0816-050-FI2022-11-14
04251315821064MetaSystems ProbesD-0816-050-ORD-0816-050-OR2022-11-14
04251315801035MetaSystems ProbesD-0816-050-BLD-0816-050-BL2026-03-17
04251315801097MetaSystems ProbesD-5131-999-OGD-5131-999-OG2025-11-21
04251315801103MetaSystems ProbesD-5136-999-OGD-5136-999-OG2025-11-21
04251315800960MetaSystems ProbesD-0823-500-FID-0823-500-FI2025-10-14
04251315800977MetaSystems ProbesD-0824-500-BLD-0824-500-BL2025-10-14
04251315800823MetaSystems ProbesD-6031-999-OGD-6031-999-OG2024-09-24
04251315800854MetaSystems ProbesD-0832-500-OGD-0832-500-OG2024-09-09
04251315800885MetaSystems ProbesD-6020-999-OGD-6020-999-OG2024-08-21
04251315820999MetaSystems ProbesD-0811-050-BLD-0811-050-BL2022-11-14
04251315811935MetaSystems ProbesD-0803-500-FID-0803-050-FI2023-07-20
04251315807907MetaSystems ProbesD-5069-999-OGD-5069-999-OG2022-12-05
04251315818262MetaSystems ProbesD-5069-100-OGD-5069-100-OG2022-12-05
04251315807082MetaSystems ProbesD-5072-999-OGD-5072-999-OG2022-11-29
04251315808188MetaSystems ProbesD-5080-999-OGD-5080-999-OG2022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
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
10190302007276PRIMER 100 NMOL LIQ TELIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302007283PRIMER 100 NMOL DRYLIFE TECHNOLOGIES CORPORATIONMVU2018-09-18
10190302009492Mouse IgM Purified AntibodyLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009508Mouse IgM FITC ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
10190302009515Mouse IgM R-PE ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-07-02
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
10190302010467Human CD14 Alexa Fluor® 700 ConjugateLIFE TECHNOLOGIES CORPORATIONMVU2018-05-06