FDA.reportPublic FDA data

FORA

Primary DI
80816042014549
Brand
FORA
Company
FORA CARE INC.
Model
Test N'GO Advance Voice
Device description
Lactate Test Strip
Published
2025-05-06
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
KHPAcid, Lactic, Enzymatic Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816042014543PrimaryGS10
80816042014549Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816042014543008160420145438160420145430816042014543
8081604201454980816042014549

GMDN Terms#

Term, Definition table
TermDefinition
Lactate monitoring system IVD, home-useA collection of devices including a dedicated, portable, electrically-powered instrument (self-testing meter) reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of lactate in a whole blood specimen.; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is typically used to monitor physical performance and conditioning in sport, and/or to support patient management.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004340807
Device count
10
DM exempt
false
Premarket exempt
true
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
00816042014543FORAFORA CARE INC.KHP2025-05-06
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSKHP2024-07-01
00380740158392ARCHITECTABBOTT IRELANDKHP2024-01-24
00380740158408AlinityABBOTT IRELANDKHP2024-01-24
00816042014505FORAFORA CARE INC.KHP2023-10-31
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866770BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
00630414305066Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00054749005505i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSKHP2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSKHP2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21
05700699441232Cleaning Solution with additive S7375 REF 944-123Radiometer Medical ApSKHP2018-09-21