Bun/BS480 BUN480

• FDA 510(k) K972671 decided 20 Jul 1997 Active
• FDA GUDID UDI-DI 00817439020284 listed 27 Sep 2016 Listed

1. 20 Jul 1997 Cleared FDA 510(k) K972671
2. 27 Sep 2016 Listed FDA GUDID 00817439020284

Trade name

Bun/BS480

Generic name

Urea IVD, kit, enzyme spectrophotometry

Model / Ref / Catalog

BUN480

Description

For the quantitative determination of urea nitrogen in serum using the Mindray BS-480 analyzer. For in vitro diagnostic use only. 8 x 60 ml, 8 x 15 ml

Primary DI / UDI-DI

00817439020284

510(k) Number

K972671 ↗

FDA product code

CDQ

GMDN term

Urea IVD, kit, enzyme spectrophotometry

Device class

Class II

Regulation number

862.1770

GUDID distribution status

In Commercial Distribution

Category: Urea IVD, kit, enzyme spectrophotometry

Other devices filed under FDA product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen).

• BUN (LIQUID) REAGENT SET by POINTE SCIENTIFIC, INC.
• ENZYMATIC BUN REAGENT by Trace Scientific, Ltd.
• OLYMPUS BUN REAGENT by Olympus Corp.
• UREA NITROGEN (BUN) LIQUID REAGENT by Jas Diagnostic, Inc.
• BUN by Carolina Liquid Chemistries Corp.
• CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN by Technicon Instruments Corp.
• PARAMAX UREA NITROGEN REAGENT by Baxter Healthcare Corp
• UREA NITROGEN (GLDH) REAGENT SET (UV) by STERLING DIAGNOSTICS INC
• BLOOD UREA NITROGEN(BUN-UV) by Reagents Applications, Inc.
• ADVIA® Chemistry UN_c Urea Nitrogen Reagents, Concentrated 10283349 6860558 by Siemens Healthcare Diagnostics Inc.

• MedTest DX Elevated HCG Control Vial Label - B HCGCTLB

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• MedTest DX HCG Control Set HCG-CTL

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

• Alt / BS480 ALT480

  Class I

  GUDID on market

• MedTest DX Elevated HCG Control Vial Label - A HCGCTLA

  Class I

  FDA 510(k) K921206 Active Cleared 29 Apr 1992 GUDID on market

See all devices from Medtest DX →