Fastep

Primary DI
00810022630402
Brand
Fastep
Company
Azure Biotech, Inc.
Model
AZC-8105
Device description
Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810022630402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810022630402008100226304028100226304020810022630402

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051286548
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810022630419FastepCOV-S35002H12023-09-22
00810022630426FastepCOV-S35002H22023-09-22
00810022630433FastepCOV-S35002H42023-09-22
00810022630440FastepCOV-S35002H202023-09-22
20810022630383FastepCOV-S23010H252023-09-22
00810022630396FastepAZC-61252023-03-14
00810022630310FastepCOV-S23010H12023-01-03
00810022630358FastepCOV-S23010H22023-01-03
00810022630365FastepCOV-S23010H42023-01-03
00810022630372FastepCOV-S23010H52023-01-03
00810022630389FastepCOV-S23010H252023-01-03