Primary Device ID | 10858945006635 |
NIH Device Record Key | 8d0296e4-5739-4837-9648-1c7c968f8470 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AlereTM iScreen® OFD |
Version Model Number | I-DCT-B702 |
Company DUNS | 019410187 |
Company Name | Instant Technologies, Inc. |
Device Count | 25 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com | |
Phone | 1-800-340-4029 |
Qa.Portsmouth@abbott.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858945006638 [Unit of Use] |
GS1 | 10858945006635 [Primary] |
MRS | Test System, Nicotine, Cotinine, Metabolites |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-12-11 |
Device Publish Date | 2016-09-24 |
30817405024033 - iScreen™ | 2024-01-05 9 Panel Privacy EUO Oral Fluid COC20, OPI40, MDMA50, OXY20, THC40, 6AM/HRN10, MET50, AMP50, PCP10 |
30817405024040 - iScreen™ | 2024-01-05 11 Panel Privacy EUO Oral Fluid BUP5, AMP50, MDMA50, COC20, OXY20, BAR50, OPI40, BZO10, MET50, MTD30, THC40 |
30817405024057 - iScreen™ | 2023-12-15 5 Panel Privacy EUO Oral Fluid MET50, OXY20, OPI40, AMP50, COC20 |
30817405024064 - iScreen™ | 2023-12-15 6 Panel Masked EUO Oral Fluid AMP50, THC40, OXY20, COC20, MET50, OPI40 |
30817405024026 - iCassette | 2023-12-08 CLIA Waived FTY/FYL 1ng/ml Cassette |
30817405024002 - iScreen™ | 2023-06-02 5 panel CLIA Waived Urine Dip Card AMP1000, COC300,OPI2000,PCP25,THC50 |
30817405024019 - iScreen™ | 2023-06-02 5 panel CLIA Waived Urine Dip Card AMP1000, COC300, MET1000, OPI2000, THC50 |
30817405023814 - iScreen™ | 2023-05-09 12 Panel CLIA Waived Flat Cup w/ SVT AMP1000, BAR300, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TH |