FDA.report

Pointe Multi-Analyte E DAU Low Calibrator

Primary DI
00811727017697
Brand
Pointe Multi-Analyte E DAU Low Calibrator
Company
POINTE SCIENTIFIC, INC.
Model
60-MA1784-15
Catalog number
60-MA1784-15
Device description
Pointe Multi-Analyte E DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set E Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urineon a number of automated clinical chemistry analyzers.
Published
2020-09-25
Public version status
New
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

Contact Domains

Product Codes

CodeName
DKBCalibrators, Drug Mixture

Product Code Classifications

CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811727017697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727017697008117270176978117270176970811727017697

GMDN Terms

TermDefinition
Multiple drugs of abuse 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 one or multiple drugs of abuse in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-445-9853techservice@medtestdx.com

Regulatory Flags

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
true
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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