ANTI-HLA-DR AM154-5M

GUDID 00810119672384

BIOGENEX LABORATORIES

HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody HLA-DR antigen tissue typing IVD, antibody

Primary Device ID	00810119672384
NIH Device Record Key	82c6bf97-83f6-477c-b21d-7d698f3baf2d
Commercial Distribution Status	In Commercial Distribution
Brand Name	ANTI-HLA-DR
Version Model Number	AM154-5M
Catalog Number	AM154-5M
Company DUNS	042697045
Company Name	BIOGENEX LABORATORIES
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Dimensions

Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter
Total Volume	6 Milliliter

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C
Special Storage Condition, Specify	Between 0 and 0 *2-8°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810119672384 [Primary]

FDA Product Code

NJT	Immunohistochemistry Reagents And Kits

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-04-06
Device Publish Date	2023-03-29

On-Brand Devices [ANTI-HLA-DR]

00810119672384	AM154-5M
00810119675972	MU154-UC