FDA.reportPublic FDA data

Mid Range AED II

Primary DI
B800727410
Brand
Mid Range AED II
Company
UTAK LABORATORIES, INC.
Model
72741
Catalog number
72741
Device description
MR AED II
Published
2020-04-15
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
DIFDrug Mixture Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B800727415PackageHIBCC5In Commercial Distribution
B800727410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
888-882-5522welovecontrol@utak.com

Regulatory Flags#

DUNS number
092519016
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
B800OPIBENZO2V4UFGML0OPI PLUS BENZO LEVEL 2 V4OPI+ BENZO 2 V4 U F GMLOPI+ BENZO 2 V4 U F GML2026-05-26
B800MORGLUC500WBFHCME0MORPHINE GLUCURONIDE 500 NG/MLMOR GLUC 500 WB F HCMEMOR GLUC 500 WB F HCME2026-04-22
B800SGULCLC0SPECIFIC GRAVITYB800SGULCLC0B800SGULCLC02026-04-22
B800DA3UFDAC0DRUGS OF ABUSE LEVEL 3DA 3 U F DACDA 3 U F DAC2026-04-16
B800FENTWBV2OCMENY0FENTANYL PLUSFENT+ WB V2 OCMENYFENT+ WB V2 OCMENY2026-04-10
B800PM100WBCMENY0PAIN 100 NG/MLPM 100 WB CMENYPM 100 WB CMENY2026-04-10
B800FENT5UFSMC0FENTANYL 5 NG/MLFENT 5 U F SMCFENT 5 U F SMC2026-04-07
B8007HMG75UFKP07-HMG 75 NG/ML7-HMG 75 U F KP7-HMG 75 U F KP2026-04-02
B800AMINCAL1BPFNHI0 AMINO ACID CAL 1 BAMIN CAL1B P F NHIAMIN CAL1B P F NHI2026-04-01
B800AMINOACIDQC2B0AMINO ACID QC 2 BAMIN QC2B P F NHIAMIN QC2B P F NHI2026-04-01
B800AMINQC1BPFNHI0AMINO ACID QC 1 BAMIN QC1B P F NHIAMIN QC1B P F NHI2026-04-01
B800DAU2V2ID0 DRUGS OF ABUSE LEVEL 2 V2DAU 2 V2 IDDAU 2 V2 ID2026-03-03
B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2DAU 2 V2 IDDAU 2 V2 ID2026-03-03
B800DAULOWV43MLUIPM0 DRUGS OF ABUSE LOW V4DAU LOW V4 3ML U IPMDAU LOW V4 3ML U IPM2026-02-25
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4DAU HIGH V4 3ML U IPMDAU HIGH V4 3ML U IPM2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4DAU LOW V4 3ML U IPMDAU LOW V4 3ML U IPM2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4DAU MID V4 3ML U IPMDAU MID V4 3ML U IPM2026-02-25
B800ETH177WBFOSBI0ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH76WBFOSBI0ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH177WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23

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