FDA.reportPublic FDA data

FABRAZYME 35MG/7ML VL1 DIAG US

Primary DI
00358468000033
Brand
FABRAZYME 35MG/7ML VL1 DIAG US
Company
GENZYME CORPORATION
Model
762620
Device description
FABRAZYME 35MG/7ML VL1 DIAG US
Published
2020-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
00358468000033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358468000033003584680000333584680000330358468000033

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.

Regulatory Flags#

DUNS number
050424395
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358468430120Seprafilm®4301-022014-09-24
00358468508621Seprafilm® Procedure Pack5086-022014-09-24
00358468638014Seprafilm® 4-section6380-012014-09-24
00358468664112Seprafilm® Single Site6641-012014-09-24
00358468664211Seprafilm® Small Incision6642-012014-09-24
00358468000071GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US7626172022-10-19
00358468000057NEOGAA AVALGLUCO 100MG/20ML MEDSU VL1 US7853612020-07-01
00358468000064OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US7853622020-07-01
00358468000019ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US7626182020-06-01
00358468000026MYOZYME 50MG/10ML MEDSU VL1 DIAG US7626192020-06-01
00358468000040CEREZYME 400IU MEDSU VL1 DIAG US7626212020-06-01
20358468019114Synvisc-One®0024012014-09-24
00358468019103Synvisc®0023902014-09-25
20358468019039LeGoo® LG100LG1002014-09-24
20358468019046LeGoo® LG250LG2502014-09-24

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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
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
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05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19