FDA.report

ANTI-CD21

Primary DI
00810119672124
Brand
ANTI-CD21
Company
BIOGENEX LABORATORIES
Model
AN745-5M
Catalog number
AN745-5M
Published
2023-04-05
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
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810119672124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119672124008101196721248101196721240810119672124

GMDN Terms

TermDefinition
CD21 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 CD21 cell marker in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume6Milliliter

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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