FDA.reportPublic FDA data

FORA

Primary DI
80816042015065
Brand
FORA
Company
FORA CARE INC.
Model
GTel/Test N'GO Advance/Test N'GO Advance Voice/Tes
Device description
Blood Ketone 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
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042015069PrimaryGS10
80816042015065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042015069008160420150698160420150690816042015069
8081604201506580816042015065

GMDN Terms#

Term, Definition table
TermDefinition
Ketone (acetoacetate) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of ketone (acetoacetate) in a clinical specimen.

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
00816042013652FORATest N'GO Advance Pro2026-07-20
00816042016516FORAP20b2026-07-20
00898939002758FORAP20v2026-07-20
00816042016080FORATest N'GO Advance2026-06-24
00816042013638FORA30G2026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.JIN2026-07-31
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.JIN2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.JIN2026-07-30
00860015091604KetoBMKETOBM USA LLCJIN2026-07-14
00860015091628KetoBMKETOBM USA LLCJIN2026-07-14
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIN2026-06-03
00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18