FDA.report

ANTI-CD45 COCKTAIL

Primary DI
00810119675804
Brand
ANTI-CD45 COCKTAIL
Company
BIOGENEX LABORATORIES
Model
MU371-UC
Catalog number
MU371-UC
Published
2023-05-05
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

Related Records

Contact Domains

Product Codes

CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810119675804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119675804008101196758048101196758040810119675804

GMDN Terms

TermDefinition
CD45 leukocyte common antigen cell marker 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 CD45 leukocyte common antigen cell marker in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume1Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C

Sterilization Methods

Method

Contacts

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

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