Microalbumin, R1 1 x 45 mL, R2 1 x 5 mL, CAL 1 x 1 mL

Organization name

Chronolab Systems, S.L.

SRN

ES-MF-000017043

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  R1, R2 and µALB-CAL: : H317 - May cause an allergic skin reaction. Contains 2-Methylisothiazol-3(2H)-one (Proclin 950). Follow the precautionary statements given in MSDS and label of the product.
• CW008

  Components from human origin have been tested and found to be negative for the presence of HBsAg, HCV, and antibody to HIV (1/2). However handle cautiously as potentially infectious.

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Trade name

Microalbumin, R1 1 x 45 mL, R2 1 x 5 mL, CAL 1 x 1 mL

UDI-DI code

D-084360386806806H7

Basic UDI-DI

B-084360386806806H7

Reference / catalog number

101-0481

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Kit content: Reagent 1 (Diluent), Reagent 2 (Latex), Albumin calibrator (Human serum) All components are ready to use. Additional equipment needed: Standard laboratory equipment.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010309ALBUMIN (IC) INCL. UALBUMIN

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification