FDA.report

Norbuprenorphine DAU Calibrator, Intermediate Calibrator #2

Primary DI
00869335000273
Brand
Norbuprenorphine DAU Calibrator, Intermediate Calibrator #2
Company
LIN-ZHI INTERNATIONAL, INC.
Model
A68829
Catalog number
A68829
Device description
5mL/bottle. Concentration: 40 ng/mL of Norbuprenorphine.
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
DLJCalibrators, Drug Specific

Product Code Classifications

CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00869335000273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00869335000273008693350002738693350002730869335000273

GMDN Terms

TermDefinition
Buprenorphine IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of buprenorphine 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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