FDA.reportPublic FDA data

Precision Xtra

Primary DI
00093815707455
Brand
Precision Xtra
Company
ABBOTT DIABETES CARE INC
Model
70745
Catalog number
70745
Device description
Precision Xtra Blood ß-Ketone Test Strips
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060768000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060768000PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPSAbbott Diabetes Care, Inc.2006-04-21JIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30093815707456PackageGS112In Commercial Distribution
00093815707455PrimaryGS10
57599-0745-1SecondaryNDC/NHRIC0
10093815707452Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3009381570745630093815707456
00093815707455000938157074550938157074550093815707455
1009381570745210093815707452

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte monitoring system IVD, point-of-careA collection of devices that includes one or more portable, electrically-powered instruments (meter), reagents, test strips and/or other associated materials and accessories [e.g., control solutions, lancets] intended to be used together exclusively at the point-of-care by medical professionals for the quantitative measurement of more than one clinical chemistry analyte [e.g., glucose, ketones, lipid(s), and/or creatinine] in a whole blood specimen. Some types may also include measurement of haemoglobin and/or haematocrit for rapid diagnosis of anaemia and/or blood loss.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-3339xx@xx.xx

Regulatory Flags#

DUNS number
966390890
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00357599835019FreeStyle Libre 2 Plus78747787472025-07-25
00357599836016FreeStyle Libre 2 Plus78749787492025-07-25
00357599880002Instinct78893788932025-09-22
00357599843014FreeStyle Libre 3 Plus78769787692025-07-25
00357599844011FreeStyle Libre 3 Plus78768787682025-07-25
00357599850005Lingo78782-0178782-012025-11-17
00357599820015FreeStyle Libre 372079720792025-07-25
00357599821012FreeStyle Libre 372078720782025-06-25
00357599842017FreeStyle Libre 378754787542025-07-25
00357599833008Abbott78632786322023-01-20
00357599001025FreeStyle Libre 14 day71939719392018-10-10
30357599880003Instinct78893788932025-09-22
00357599803018FreeStyle Libre 271953719532025-07-25
00357599805012FreeStyle Libre 271951719512025-07-25
00357599804015FreeStyle Libre 271952719522025-07-25
30357599805013FreeStyle Libre 271951719512025-07-25
30357599820016FreeStyle Libre 372079720792025-07-25
30357599835010FreeStyle Libre 2 Plus78747787472025-07-25
30357599836017FreeStyle Libre 2 Plus78749787492025-07-25
30357599842018FreeStyle Libre 378754787542025-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIN2026-04-16
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
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
00850014861681heartscare B-Ketone Test Strips (10pcs/Box)Hearts Bio, Inc.JIN2025-10-01
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
00816042015076FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06