N/A 711F01

GUDID 00850019007343

6-Panel Drug Screen Dip Card Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00850019007343
NIH Device Record Key3c6fe834-6c9e-4c84-97a1-85d1200744ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number711F01
Catalog Number711F01
Company DUNS795658603
Company NameCHEMTRON BIOTECH INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019007343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-24

On-Brand Devices [N/A]

008500190078245-Panel DOA Dip Card, AMP/COC/MET/OPI2000/THC, 25 tests/kit
0085001900770112-Panel DOA Dual Chamber Cup, AMP300/BAR200/BUP10/BZO200/ COC150/MDMA/MET300/MTD300/OPI300/OXY/
008500190076337-Panel DOA Cup, AMP300/BZO200/COC150/MET300/OPI300/OXY/THC - 25tests/kit
008500190075727-Panel DOA Dip Card THC/COC/MOR300/AMP/MET/BZO/MDMA, 25pcs/kit
008500190075654-Panel Drug Screen Dip Card Tests, COC/THC/MET/AMP, 25pcs/kit
008500190075415-Panel DOA Cup, COC/MET/OPI2000/PCP/THC, 25tests/kit
0085001900753410-Panel DOA Dip Card Test, AMP/BAR/BZO/COC/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
0085001900742812-Panel Drug Screen Cup Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
008500190074045-Panel DOA Cup, AMP/COC/MET/MOR300/THC, 25pcs/kit
0085001900739811-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET/AMP/PCP/BZO/BAR/MTD/OXY/MDMA, 25pcs/kit
008500190073506-Panel DOA Dip Card, THC/COC/BAR/AMP/OPI2000/MDMA, 25pcs/kit
008500190073436-Panel Drug Screen Dip Card Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit
008500190073295-Panel Drug Screen Dip Card Tests, AMP/COC/OPI2000/PCP/THC, 25pcs/kit
008500190073055-Panel Drug Screen Dip Card Tests, AMP/COC/MET/MOR300/THC, 25pcs/kit
008500190072994-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET, 25pcs/kit
008500190072753-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
00850019007145BUP Dip Card Test, 25pcs/kit
008500190070396-Panel Drug Screen Cup Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit
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