FDA.reportPublic FDA data

QMedix™

Primary DI
00894175000091
Brand
QMedix™
Company
Diagnostic Automation, Inc.
Model
DACD121089-1-21
Catalog number
121089-1-21
Device description
QMedix™ 5-Drug RapiDip InstaTest (OPI/COC/PCP/MET/THC)
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
LAFGas Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894175000091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894175000091008941750000918941750000910894175000091

GMDN Terms#

Term, Definition table
TermDefinition
Multiple therapeutic drugs/drugs of abuse IVD, kit, thin layer chromatographyA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen, using a thin layer chromatography method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8185913030Onestep@rapidtest.com

Regulatory Flags#

DUNS number
878252071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054026446AccuDiag™ T3 ELISA KitDACD3144-153144-152026-03-02
00850082766024AccuDiag™ Mycoplasma pneumoniae IgG ELISADACD8042-28042-22026-03-02
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA DACD2506-22506-22026-02-27
00850049545433AccuDiag™ Prolactin (PRL) ELISADACD4226-154226-152026-01-30
00850054026712AccuDiag™ LH ELISADACD4225-154225-152026-01-30
00894175000800AccuDiag™ Progesterone ELISADACD2077-152077-152026-01-30
00850054026569QMedix™DACD5102-25102-22024-04-23
00850049545723AccuDiag™ Insulin ELISADACD1606-151606-152026-01-27
00850049545815AccuDiag™ Human Growth Hormone (HGH) ELISADACD1901-151901-152026-01-27
00850054026255AccuDiag™ C-Peptide ELISA KitDACD1293-151293-152026-01-27
00850054026682AccuDiag™ Estradiol ELISA DACD2046-152046-152026-01-27
00850054026705 AccuDiag™ FSH ELISADACD4224-154224-152026-01-27
00850082766017AccuDiag™ Free Estriol ELISA DACD3171-153171-152026-01-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADACD1292-151292-152026-01-27
00894175000824AccuDiag™ ANST (Androstenedione) ELISADACD1038-151038-152026-01-27
10850049545492QMedix™DACD104110-1-19104110-1-192025-12-24
10850082766007QMedix™DACD113030-1-19113030-1-192025-12-24
00850049545501Diagnostic Automation, Inc.DAI SF2100SF21002025-12-24
00850054026392Diagnostic Automation, Inc.DAI SF2600SF26002025-12-24
00850049545495QMedix™DACD104110-1-19104110-1-192025-12-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLDJ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyLAF2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LCM2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DJG2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.LAF2026-09-24
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DIO2026-09-24
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LCM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01