FDA.reportPublic FDA data

FORA

Primary DI
80816042015034
Brand
FORA
Company
FORA CARE INC.
Model
GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes
Device description
Blood Glucose Test Strips
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173505000FORA GTel Blood Glucose Monitoring SystemForacare, Inc.2018-08-09NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042015038PrimaryGS10
80816042015034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042015038008160420150388160420150380816042015038
8081604201503480816042015034

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004340807
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00816042014543FORATest N'GO Advance Voice2025-05-06
00816042015045FORASpiro10b2026-05-18
00816042015052FORASpiro10b2026-05-18
00816042016417FORAGTel/Test N'GO Advance/Test N’GO Advance Voice/Tes2026-03-20
00816042016387FORATest N'GO Advance/Test N'GO Advance Voice2026-04-27
00816042013577FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Goj2020-12-22
00816042013669FORATest N'GO Advance Pro 2020-05-05
00816042013881ForaCareGD202020-04-06
00816042013911FORAG202023-07-03
00816042015038FORAGTel/Test N'GO Advance/Test N'GO Advance Voice/Tes2024-10-01
00816042013850FORA 6 Connect2020-02-17
00816042010200FORAV10/D10/D202016-12-20
00816042010675FORAV30/G30/Premium V102016-11-15
00816042010828ForaCareGD202017-04-03
00816042010859Pet GlucoPet Gluco2018-08-07
00816042011221FORAGD502017-04-04
00816042011610FORAG20/D302017-05-09
00816042011634FORAMD2017-06-13
00816042011665FORAD40/G312017-05-16
00816042011672FORAV30/G30/Premium V102017-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00021292015381TRUE METRIX PROTRIVIDIA HEALTH, INC.LFR2025-12-02
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.LFR2025-12-01
00301939628021CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2025-01-06
00353885012836OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2024-01-31
00353885012799OneTouch Verio FlexLifeScan Europe GmbHLFR2023-05-26
40301939660517CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXTASCENSIA DIABETES CARE US INC.LFR2022-11-23
00353885012102OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012621OneTouch Ultra Plus FlexLifeScan Europe GmbHLFR2022-08-31
00353885012638OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012645OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012683OneTouch Ultra PlusLifeScan Europe GmbHLFR2022-08-31
00353885012485OneTouch Verio FlexLifeScan Europe GmbHLFR2022-05-19
00301937828010CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2022-01-07
00301939550018CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-12-08
00301937825019CONTOUR® NEXT ONEASCENSIA DIABETES CARE US INC.LFR2021-11-22
00353885012423OneTouch VerioLifeScan Europe GmbHLFR2021-09-18
00021292014797TRUE METRIXTRIVIDIA HEALTH, INC.LFR2021-08-06
00301937553011CONTOUR® NEXT EZASCENSIA DIABETES CARE US INC.LFR2021-07-30
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.LFR2020-08-19
00353885012188OneTouch VerioLifeScan Europe GmbHLFR2020-06-30
50096295139551TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-05-11
00357599807009FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00357599808006FreeStyle Precision ProABBOTT DIABETES CARE INCLFR2020-04-15
00353885012034OneTouch VerioLifeScan Europe GmbHLFR2020-04-12
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-04-10
10021292014299TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-03-18
10021292014305TRUE METRIXTRIVIDIA HEALTH, INC.LFR2020-03-18