FDA.reportPublic FDA data

ANTI-HLA-DR

Primary DI
00810119675972
Brand
ANTI-HLA-DR
Company
BIOGENEX LABORATORIES
Model
MU154-UC
Catalog number
MU154-UC
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00810119675972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119675972008101196759728101196759720810119675972

GMDN Terms#

Term, Definition table
TermDefinition
HLA class II tissue typing IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing for one or multiple HLA class II antigens (i.e., HLA-D) in a clinical specimen, using techniques which may include complement-dependent cytotoxicity (CDC), enzyme immunoassay (EIA) and/or flow cytometry.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Milliliter

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810119676733ANTI-HER2/ERBB2AY726-YCDAY726-YCD2023-05-04
00810119679062ANTI-C-ERBB-2NU753-UCNU753-UC2023-04-25
00810119677433Anti- HER2/ERBB2 PHOSPHO (PY877)NU726-UCNU726-UC2023-04-21
00810119676443ANTI-HER2/ERBB2AN726-5MAN726-5M2023-04-20
00810119674395ANTI- HER2/ERBB2NU726-5UCNU726-5UC2023-04-19
00810119674562ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-19
00810119674890ANTI- HER2/ERBB2NU726-UCNU726-UC2023-04-19
00810119673541ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-18
00810119671363ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-04-03
00810119674876ANTI-C-ERBB-2 (HER-2/NEU)MU134-UCMU134-UC2023-03-29
00810119670069ANTI-HER2/ERBB2AN726-5MAN726-5M2023-03-28
00810119670373ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-03-28
00810119670168ANTI-HER2/ERBB2AN726-10MAN726-10M2023-03-27
00810119673923ANTI-VIPAR530-5RAR530-5R2023-05-12
00810119678713ANTI-VIPPU530-UPPU530-UP2023-04-24
00810119673169ANTI-TAUAM412-5MAM412-5M2023-04-17
00810119672513ANTI-TAUAM459-5MAM459-5M2023-04-06
00810119671202ANTI-BETA-HCGAM395-5MAM395-5M2023-03-31
00810119673411TRIS WASH BUFFERHK098-5KHK098-5K2023-05-12
00850646007341DiluentHK156-5KEHK156-5KE2023-05-19

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