ARKRAY USA, INC.

Address:Yousuien-nai,Kamigyo-ku Kyoto,JP

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lancet, Blood (FMK) (7) Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) (JMT) (1) Hemoglobin A1c Test System (PDJ) (1) Urinalysis Controls (Assayed And Unassayed) (JJW) (1)

Premarket Exempt

No Yes

Clear

Assure® Lance Safety Lancets - 00015482980184 Catalog Number :

Device Description : Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet shoul Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Assure® Lance Safety Lancets - 00015482980221 Catalog Number :

Device Description : Assure Lance Safety Lancets 21g 200's. Single-use disposable blood lancet shoul Assure Lance Safety Lancets 21g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Assure® Lance Safety Lancets - 00015482980283 Catalog Number :

Device Description : Assure Lance Safety Lancets 28g 200's. Single-use disposable blood lancet shoul Assure Lance Safety Lancets 28g 200's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Assure® Lance Safety Lancets - 00015482981211 Catalog Number :

Device Description : Assure Lance Safety Lancets 21g 100's. Single-use disposable blood lancet shoul Assure Lance Safety Lancets 21g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Assure® Lance Safety Lancets - 00015482983284 Catalog Number : N/A

Device Description : Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for assisted blood drawn by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 30

Assure® Lance Plus Safety Lancets - 00015482991258 Catalog Number :

Device Description : Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet Assure Lance Plus Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Assure® Lance Plus Safety Lancets - 00015482991302 Catalog Number :

Device Description : Assure Lance Plus Safety Lancets 30g 100's. Single-use disposable blood lancet Assure Lance Plus Safety Lancets 30g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

Device Class :

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

S.G. Calibrator H - 04987486001959 Catalog Number :

Device Description : The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID The S.G. Calibrator H is used to calibrate specific gravity on the AUTION HYBRID AU-4050, AUTION MAX AX-4030 and AUTION MAX AX-4280 Urine Analyzers. The calibration is scheduled to occur monthly or as needed.

Device Class : 1

Duns Number: 008171162

Premarket Exempt : No

Product Code : JMT

Prescription Use : No

Device Count : 1

ADAMS™ A1c HA-8180V (UL) Analyzer - 04987486001973 Catalog Number :

Device Description : The ADAMS A1c HA-8180V system is intended for the quantitative determination of The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).

Device Class : 2

Duns Number: 008171162

Premarket Exempt : No

Product Code : PDJ

Prescription Use : Yes

Device Count : 1

AUTION Check Plus Controls - 04987486009801 Catalog Number :

Device Description : Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.)

Device Class : 1

Duns Number: 008171162

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : Yes

Device Count : 1

Previous 1 … 15 16 17 18 19 Next