FDA.report

AlereTM iScreen®

Primary DI
10858945006406
Brand
AlereTM iScreen®
Company
Instant Technologies, Inc.
Model
IS1MTD
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications

CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10858945006406PrimaryGS10
00858945006409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085894500640610858945006406
00858945006409008589450064098589450064090858945006409

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-340-4029Qa.Portsmouth@abbott.com

Regulatory Flags

DUNS number
019410187
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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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30817405023821iScreen™ABTDOAW111701AABTDOAW111701A2023-05-01
30817405023838iScreen™ABTDUAW112706FABTDUAW112706F2023-05-01
30817405023845iScreen™ABTDUAW114703CABTDUAW114703C2023-05-01
30817405023852iScreen™ABTDOAW15701AABTDOAW15701A2023-05-01
30817405023869iScreen™ABTDOAW15702BABTDOAW15702B2023-05-01
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