FDA.reportPublic FDA data

MetaSystems Probes

Primary DI
04251315820999
Brand
MetaSystems Probes
Company
MetaSystems Probes GmbH
Model
D-0811-050-BL
Catalog number
D-0811-050-BL
Device description
XCE 11 blue, Centromere-Specific Probe
Published
2022-11-14
Public version status
Update
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
04251315820999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251315820999042513158209994251315820999

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
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
04251315809444MetaSystems ProbesD-7003-250-GLD-7003-250-GL2022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05