Rapid Response 10 Panel Saliva Test Cup E/I Screening

GUDID 00722066006832

Rapid Response 10 Panel Saliva Test Cup E/I Screening (D10.42-2FC1E)- AMP50, BAR50, COC20, MTD30, MET50, MDMA50, OPI40, OXY20, PCP10, THC40. For employment and insurance testing.

BTNX Inc

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00722066006832
NIH Device Record Key26b6af1a-82b2-4570-9b3c-d51e614584e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapid Response 10 Panel Saliva Test Cup E/I Screening
Version Model NumberD10.42-2FC1E
Company DUNS251005005
Company NameBTNX Inc
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100722066006832 [Unit of Use]
GS110722066006839 [Primary]

FDA Product Code

PUXTest, Amphetamine, Employment And Insurance Testing, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-19
Device Publish Date2023-05-11

Devices Manufactured by BTNX Inc

00722066008294 - Rapid Response2024-08-23 12 Panel DOA Cup (12.11) - MOP300 OXY100 BZO300 OPI2000 MET1000 AMP1000 COC300 THC50 MDMA500 BUP10 BAR300 MTD300
10722066008345 - Rapid Response 2024-08-23 One Step 6 Panel DOA Cup (6.65) - AMP1000, BUP10, BZO300, COC300, OPI2000, OXY100
00722066009017 - Rapid Response2024-08-23 10 Panel DOA Cup (10.46) -OXY100 MDMA500 COC150 BZO300 MTD300 BUP10 MET500 MOR300 AMP500 THC50
00722066008249 - Rapid Response2024-08-22 Rapid Response Fentanyl Test Cassette
00722066008379 - Rapid Response2024-08-22 Rapid Response Saliva Drug Test (COT)
00722066008614 - Rapid Response2024-08-22 D4.59-1VF- AMP1000 COC300 MOP2000 PCP25
00722066008621 - Rapid Response2024-08-22 Rapid Response Fentanyl Test Cassette
00722066008850 - Rapid Response2024-08-22 D9.28-1VF- MTD300 EDDP300 MOP300 BUP10 BZO300 COC300 AMP1000 BAR300 THC50

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