FDA.report

Hydrocodone 100 DAU Control, Level 2 Control

Primary DI
B07603880
Brand
Hydrocodone 100 DAU Control, Level 2 Control
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0388
Catalog number
0388
Device description
5mL/bottle. Concentration: 125 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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LASDrug Specific Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07603880PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
840839190
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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