FDA.reportPublic FDA data

Hydrocodone 300 DAU Control, Level 2 Control

Primary DI
B07603980
Brand
Hydrocodone 300 DAU Control, Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0398
Catalog number
0398
Device description
5mL/bottle.Concentration: 375 ng/mL of Hydrocodone.
Published
2016-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07603980PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
840839190
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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