FDA.report

High Range AED II

Primary DI
B800727405
Brand
High Range AED II
Company
UTAK LABORATORIES, INC.
Model
72740
Catalog number
72740
Device description
HR AED II
Published
2020-04-15
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
DIFDrug Mixture Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B800727405PackageHIBCC5In Commercial Distribution
B800727400PrimaryHIBCC0

GMDN Terms

TermDefinition
Multiple anticonvulsant therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
888-882-5522welovecontrol@utak.com

Regulatory Flags

DUNS number
092519016
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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