FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405000678
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
Mob080
Device description
Neurofilament, Clone 2F11, 1 ml
Published
2026-06-09
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
true

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405000678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405000678008464050006788464050006780846405000678

GMDN Terms#

Term, Definition table
TermDefinition
Neurofilament protein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of neurofilament protein [e.g., neurofilament light protein (NF-L), neurofilament protein M (NF-M) and/or neurofilament heavy protein (NF-H)] in a clinical specimen.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00846405016808Diagnostic BioSystemsC0062026-07-09
00846405016822Diagnostic BioSystemsC0042026-07-09
00846405016839Diagnostic BioSystemsC0052026-07-09
00846405016846Diagnostic BioSystemsC0022026-07-09
00846405020102Diagnostic BioSystemsC002-NI2026-07-09
00846405020119Diagnostic BioSystemsC004-NI2026-07-09
00846405020126Diagnostic BioSystemsC005-NI2026-07-09
00846405020133Diagnostic BioSystemsC006-NI2026-07-09
00846405000166Diagnostic BioSystemsMob5692026-06-09
00846405000173Diagnostic BioSystemsMob569-052026-06-09
00846405000180Diagnostic BioSystemsMob569-012026-06-09
00846405000685Diagnostic BioSystemsMob080-052026-06-09
00846405000692Diagnostic BioSystemsMob080-012026-06-09
00846405000760Diagnostic BioSystemsMob0592026-06-09
00846405000777Diagnostic BioSystemsMob059-052026-06-09
00846405000784Diagnostic BioSystemsMob059-012026-06-09
00846405000791Diagnostic BioSystemsMob0542026-06-09
00846405000807Diagnostic BioSystemsMob054-052026-06-09
00846405000814Diagnostic BioSystemsMob054-012026-06-09
00846405001156Diagnostic BioSystemsMob2782026-06-09

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00840542210945ANTI-KRASBIOGENEX LABORATORIESNJT2026-09-18
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00840542211201Anti-CD82BIOGENEX LABORATORIESNJT2026-09-18
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