FDA.reportPublic FDA data

Normal Range Trace Elements

Primary DI
B800668160
Brand
Normal Range Trace Elements
Company
UTAK LABORATORIES, INC.
Model
66816
Catalog number
66816
Device description
NR Trace Elements
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B800668165PackageHIBCC5In Commercial Distribution
B800668160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple heavy metal IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple heavy metals 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B800ETOH120UFMNPD0ETHANOL 120 MG/DLETOH 120 U F MNPDETOH 120 U F MNPD2026-10-20
B800UTAKSCPREG1SFSD0PREGNENOLONE PLUS 1UTAK-SC PREG+1 S F SDUTAK-SC PREG+1 S F SD2026-10-20
B800UTAKSCPREG2SFSD0PREGNENOLONE PLUS 2UTAK-SC PREG+2 S F SDUTAK-SC PREG+2 S F SD2026-10-20
B800DAU2SUID0DAU 2 SU IDDAU 2 SU IDDRUGS OF ABUSE LEVEL 22026-10-15
B800ISACAL1V2SFUCSF0ISAVUCONAZOLE PLUS CALIBRATOR 1 V2ISA+ CAL 1 V2 S F UCSFISA+ CAL 1 V2 S F UCSF2026-10-07
B800BUP5WBFMSP0BUPRENORPHINE 5NG/MLBUP 5 WB F MSPBUP 5 WB F MSP2026-08-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1BUS 1 DP F EUHBUS 1 DP F EUH2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2BUS 2 DP F EUHBUS 2 DP F EUH2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3BUS 3 DP F EUHBUS 3 DP F EUH2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4BUS 4 DP F EUHBUS 4 DP F EUH2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5BUS 5 DP F EUHBUS 5 DP F EUH2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6BUS 6 DP F EUHBUS 6 DP F EUH2026-08-26
B800FENTHIGHWBSCFL0FENTANYL PLUS HIGHFENT+ HIGH WB SCFLFENT+ HIGH WB SCFL2026-07-14
B800FENTLOWWBSCFL0FENTANYL PLUS LOWFENT+ LOW WB SCFLFENT+ LOW WB SCFL2026-07-14
B800LCDOAWBFMSP0DRUGS OF ABUSELCDOA WB F MSPLCDOA WB F MSP2026-07-07
B800THCCTLMFMSP0THC CONTROLTHC CTL M F MSPTHC CTL M F MSP2026-07-07
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

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