FDA.reportPublic FDA data

eREADER+ Drug Screening Instrument

Primary DI
00816565021547
Brand
eREADER+ Drug Screening Instrument
Company
AMEDITECH INC.
Model
55161
Device description
ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni.
Published
2020-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816565021547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816565021547008165650215478165650215470816565021547

GMDN Terms#

Term, Definition table
TermDefinition
Photometric immunoassay analyser IVDA portable, electrically-powered instrument, intended to be used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument uses photometry to detect visual markers that result from the immunological reaction between the reagents and the specimen. It is intended to be used by health professionals for rapid in vitro diagnostic measurements at the point-of-care or in the laboratory.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure81 KiloPascal101 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
619-318-4969angela.occhionero@abbott.com
619-372-6179Irene.Yasuda@abbott.com

Regulatory Flags#

DUNS number
010551716
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816565020366KNOWme™88433884332023-05-01
00816565020373KNOWme™88453884532023-05-01
00816565020380KNOWme™88431884312023-05-01
00816565021530eCUP + Drug Screening Device94615946152020-03-17
00816555020390ToxCup Drug Screen CupHT23HT232018-10-08
00816565020007ImmuTest Drugs of Abuse Screen CardIMD-AMPIMD-AMP2016-09-01
00816565020014ImmuTest Drugs of Abuse Screen CardIMD-BARIMD-BAR2016-09-01
00816565020021ImmuTest Drugs of Abuse Screen CardIMD-BZOIMD-BZO2016-09-01
00816565020038ImmuTest Drugs of Abuse Screen CardIMD-COCIMD-COC2016-09-01
00816565020045ImmuTest Drugs of Abuse Screen CardIMD-METIMD-MET2016-09-01
00816565020052ImmuTest Drugs of Abuse Screen CardIMD-OPI300IMD-OPI3002016-09-01
00816565020069ImmuTest Drugs of Abuse Screen CardIMD-THCIMD-THC2016-09-01
00816565020076ImmuTest Drugs of Abuse Screen CardIMD-12MO3IMD-12MO32016-09-01
00816565020083ImmuTest Drugs of Abuse Screen CardIMD-8MTIMD-8MT2016-09-01
00816565020090ImmuTest Drugs of Abuse Screen CardIMD-5BO300IMD-5BO3002016-09-01
00816565020106ImmuTest Drugs of Abuse Screen CardIMDA-3MIMDA-3M2016-09-01
00816565020113ImmuTest Drugs of Abuse Screen CardIMDA-5MIMDA-5M2016-09-01
00816565020120ImmuTest Drugs of Abuse CupIMC-3PIMC-3P2016-09-01
00816565020137ImmuTest Drugs of Abuse CupIMC-5BO3IMC-5BO32016-09-01
00816565020144ImmuTest Drugs of Abuse CupIMC-5MIMC-5M2016-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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