FDA.reportPublic FDA data

ANTI-HER2/ERBB2

Primary DI
00810119676733
Brand
ANTI-HER2/ERBB2
Company
BIOGENEX LABORATORIES
Model
AY726-YCD
Catalog number
AY726-YCD
Published
2023-05-04
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

Contact Domains#

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
00810119676733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119676733008101196767338101196767330810119676733

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein 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 c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 421-4149support@biogenex.com

Regulatory Flags#

DUNS number
042697045
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
00810119675187ANTI-PAX5MU967-UCMU967-UC2023-05-19
00810119675972ANTI-HLA-DRMU154-UCMU154-UC2023-05-19
00810119676061Anti- c-MycNUC25-UCNUC25-UC2023-05-19
00810119676221LIQUID DAB, CHROMOGENHK124-50KHK124-50K2023-05-19
00810119676252H.PYLORIAM880-10MAM880-10M2023-05-19
00850646007327AEC (Aminoethylcarbazole)HK092-5KEHK092-5KE2023-05-19
00850646007334AEC Substrate PackHK129-5KEHK129-5KE2023-05-19
00850646007341DiluentHK156-5KEHK156-5KE2023-05-19
00850646007358DiluentHK157-5KEHK157-5KE2023-05-19
008506460073652-Compnent DAB PackHK542-XAKEHK542-XAKE2023-05-19
00850646007501Anti-C-myc-ProteinMU318-UCMU318-UC2023-05-19
00850646007587Anti-Inhibin-AplhaMU446-UCMU446-UC2023-05-19
00810119677006DILUENTHK156-5KHK156-5K2023-05-18
00810119677112Coverslips, 18x18 mm, Xmatrx® ELITE & InfinityXT121-XBKXT121-XBK2023-05-18
00810119677228HPV 14 PROBEPR251-YADPR251-YAD2023-05-18
00810119679055PROTEASE XXIV 4-PACK KITEK002-10KEK002-10K2023-05-18
00810119679147CONC S100 BETANU713-UCNU713-UC2023-05-18
00810119679307ANTI-MYELOPEROXIDASEAR496-10RAR496-10R2023-05-18
00810119679321H.PYLORIAY880-YCDAY880-YCD2023-05-18
00810119679437Anti-Myelin Basic ProteinMU380-UCMU380-UC2023-05-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
04251315801035MetaSystems ProbesMetaSystems Probes GmbHMVU2026-03-17
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00850051429899Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-01-24
05700575018107Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1AGILENT TECHNOLOGIES, INC.MVU2026-01-21
M663DF300120DiskFISHCELLAY, INC.MVU2026-01-06
M663DF300129DiskFISHCELLAY, INC.MVU2026-01-06
M663DF400590DiskFISHCELLAY, INC.MVU2026-01-06
M663DF402440DiskFISHCELLAY, INC.MVU2026-01-06
M663CKOF300120OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF302510OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF400590OligoFISHCELLAY, INC.MVU2026-01-06
M663OF4005903001OligoFISHCELLAY, INC.MVU2026-01-06
M663CKOF402440OligoFISHCELLAY, INC.MVU2026-01-06
00810034704009PE anti-human TdTBIOLEGEND, INC.MVU2025-12-22
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