FDA.reportPublic FDA data

First Check

Primary DI
00643281069122
Brand
First Check
Company
FIRST CHECK DIAGNOSTIC CORP.
Model
12 Drug Test
Published
2016-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643281069122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643281069122006432810691226432810691220643281069122

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing specimen collection kit IVDA covered receptacle and other associated materials/tools, available either [non-prescription] over-the-counter and/or to health professionals, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other investigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
945331317
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643281801128First CheckTHC Test- 2 pack2019-09-06
00643281061553First CheckOne Drug MarijuanaTHC2016-06-22
00643281069078First Check7 Drug Test2016-06-30
00643281067555First Check2 Drug Test2016-06-30
00643281069047First Check4 Drug Test2016-06-30
00643281710055First Check(R)14 Drug Test2018-04-11
00643881069078First Check7 Drug Test2016-06-30