FDA.report

ULTRAVIEW UNIVERSAL AP RED DETECTION KIT

Primary DI
04015630972258
Brand
ULTRAVIEW UNIVERSAL AP RED DETECTION KIT
Company
Ventana Medical Systems, Inc.
Model
05269814001
Catalog number
05269814001
Published
2021-01-29
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

Product Codes

CodeName
NJTIMMUNOHISTOCHEMISTRY REAGENTS AND KITS

Product Code Classifications

CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630972258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630972258040156309722584015630972258

GMDN Terms

TermDefinition
Immunohistochemistry conjugated secondary antibody IVDOne or multiple conjugated immunoglobulins capable of binding to specific antigenic determinants, and intended to be used for the detection of primary antibodies bound to specific cell markers when testing biological tissues or clinical specimens.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184042521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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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