FDA.report

Normal Range Trace Elements

Primary DI
B800668165
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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B800668165PackageHIBCC5In Commercial Distribution
B800668160PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Total Volume5Milliliter

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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