Liquid Unassayed Multiqual®

Levels 1, 2 and 3
697 Level 1 12 x 10 mL Level 1 56691
698 Level 2 12 x 10 mL 2024-02-29 56690 Level 2 56692
699 Level 3 12 x 10 mL Level 3 56693
698X MiniPak 3 x 10 mL

http://www.myeinserts.com/56690

INTENDED USE PROCEDURE

Liquid Unassayed Multiqual is intended for use as an unassayed quality control This product should be treated the same as patient specimens and run in
serum to monitor the precision of laboratory testing procedures for the analytes accordance with the instructions accompanying the instrument, kit, or reagent
listed in this package insert. being used.
SUMMARY AND PRINCIPLE Thawed Unopened: If the product has been stored frozen, allow it to stand at
The use of quality control materials is indicated as an objective assessment of room temperature (18 to 25°C) for approximately 1 hour or until completely
the precision of methods and techniques in use and is an integral part of good thawed. Gently swirl the contents until homogeneous with no visible signs of a
laboratory practices. Multiple levels of control are available to allow monitoring precipitate. Any precipitate present after thawing should dissolve upon mixing. If
of the test system’s reliability. performing trace metal analysis, do not mix by inversion. Store the thawed
REAGENT product at 2 to 8°C.
Thawed Opened: If the product has been stored refrigerated, allow it to reach
This product is prepared from human serum with added chemicals, drugs,
purified biochemical material (tissue extracts of human and animal origin), room temperature (18 to 25°C) before use. Minimize the time at room
stabilizers and preservatives. This product is provided in liquid form temperature. Gently swirl the vial several times to ensure homogeneity. After
for convenience. each use promptly replace the stopper and return to 2 to 8°C storage.
Aliquot-Frozen: To prepare aliquot samples, allow the control vial to thaw as
STORAGE AND STABILITY described above. Gently swirl the vial several times to ensure homogeneity, then
This product will be stable until the expiration date when stored unopened dispense the control material into aliquot vials and store at -20 to -70°C. If
at -20 to -70°C. For optimum performance, avoid storing this product in a sampling aliquot, use it only once. Discard the remaining material.
frost-free freezer. Store this product away from the light. Dispose of any discarded materials in accordance with the requirements of your
Instructions for this product when stored Thawed Unopened, Thawed Opened, local waste management authorities. In the event of damage to packaging,
or Aliquot-Frozen: The stability claims given below are from the initial date of contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories
thaw. Make a note of when the date begins. For handling instructions refer to Technical Services.
Procedure Section below.
Thawed Unopened: When thawed and stored unopened at 2 to 8°C, this LIMITATIONS
product will be stable as follows: 1. This product should not be used past the expiration date.
- All Analytes: 30 days 2. If there is evidence of microbial contamination or excessive turbidity in the
Except: product, discard the vial.
- Bilirubin (Direct): 11 days 3. This product is not intended for use as a standard.
- Cholesterol (HDL), Cholinesterase, Phosphorus and Triglycerides: 7 days 4. Values may gradually decrease over the product shelf life for the following
Bilirubin (Total) and Bilirubin (Direct) values may decrease. Alkaline Phosphatase analytes: Bilirubin (Direct), Bilirubin (Neonatal), ALT/SGPT, Cholinesterase,
activity may rise. The control must be stored frozen when using AST methods Tobramycin, Cholesterol (HDL) and Alkaline Phosphatase.
without pyridoxal-5-phosphate. 5. Methods subject to interference by ascorbic acid may exhibit suppressed
Thawed Opened: Once thawed, opened, and stored tightly capped at 2 to 8°C, uric acid recovery.
this product will be stable as follows: 6. The performance of this product has not been evaluated for use with
- All analytes: 14 days capillary electrophoresis methods.
Except: SPECIFIC PERFORMANCE CHARACTERISTICS
- Alkaline Phosphatase, AST/SGOT, Bilirubin (Neonatal) and This product is a stabilized liquid product manufactured under rigid quality
Bilirubin (Total): 9 days control standards. To obtain consistent assay values, the control requires proper
- Bilirubin (Direct), Cholesterol (HDL), Cholinesterase, Creatine Kinase (CK), storage and handling as described.
Phosphorus and Triglycerides: 7 days OPTIONAL SUPPLIES
- LAP Arylamidase: 3 days Item No. 987000 Dispenser Tips for Screw Caps (100/package).
Aliquot-Frozen: Once aliquoted and stored in tightly capped amber vials at WARNING
-20 to -70°C, this product will be stable as follows:
- All analytes: 14 days Biological source material. Treat as potentially infectious.
Discard the remaining aliquot product after use. Each human donor unit used to manufacture this product was tested as required
This product is shipped under frozen conditions. by FDA accepted methods. Tests results were non-reactive or negative for
evidence of infection due to Human Immunodeficiency Virus (HIV), Hepatitis B
Virus (HBV) and Hepatitis C Virus (HCV). This product may also contain other
human source materials for which there are no approved tests. In accordance
with good laboratory practice, all human source material should be considered
potentially infectious and handled with the same precautions used with
patient specimens.
Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.

Page 1 English • 2021-04 • 5354-00

 Liquid Unassayed Multiqual®, Levels 1, 2 and 3
ANALYTES
Acetaminophen Ceruloplasmin ◆ Haptoglobin ◆ Prostatic Acid Phosphatase (PAP) ❑
Acid Phosphatase (Total) Chloride Immunoglobulin A (IgA) ◆ Protein Serum (Total)
Albumin Cholesterol (HDL) Immunoglobulin G (IgG) ◆ Salicylate
Alkaline Phosphatase Cholesterol (LDL) Immunoglobulin M (IgM) ◆ Sodium
Alpha 1-Antitrypsin ◆ Cholesterol (Total) Iron T3 (Total)
Alpha-HBDH ◆ ❑ Cholinesterase ◆ Iron (TIBC) ◆ T3 Uptake/T Uptake
ALT/SGPT CK-MB Isoenzyme ❑ Iron (UIBC) ◆ T4 (Free)
Amikacin Complement C3 ◆ Lactate (Lactic Acid) T4 (Total)
Amylase Complement C4 ◆ Lactate Dehydrogenase (LDH) Theophylline
Amylase (Pancreatic) Copper ◆ LAP Arylamidase ◆ Thyroid Stimulating Hormone (TSH)
Apolipoprotein A-I ◆ Cortisol Lipase Tobramycin
Apolipoprotein B ◆ Creatine Kinase (CK) Lithium Transferrin ◆
AST/SGOT Creatinine Magnesium Triglycerides
Bilirubin (Direct) Digoxin Osmolality Urea
Bilirubin (Neonatal) Ethanol Phenobarbital Urea Nitrogen (BUN)
Bilirubin (Total) Ferritin ◆ Phenytoin Uric Acid
Calcium Gamma Glutamyltransferase (GGT) Phospholipids Valproic Acid
Calcium (Ionized) Gentamicin Phosphorus Vitamin B12 ◆
Carbamazepine Globulin ◆ Potassium Zinc
Carbon Dioxide (CO2) Glucose Prealbumin ◆

NOTES
◆ Endogenous levels only.
❑ No claim is made for expected value or stability of this analyte.

UNITED STATES, Bio-Rad Laboratories

9500 Jeronimo Road, Irvine, CA 92618

Bio-Rad FRANCE, Bio-Rad

3 boulevard Raymond Poincare, 92430 Marnes-la-Coquette
Laboratories Phone:(33) 1-4795-6000 / Fax:(33) 1-4741-9133

Australia, Bio-Rad Laboratories Pty. Ltd., Level 5, 446 Victoria Road, Gladesville, New South Wales 2111 • Phone +61 (2) 9914 2800 • Fax +61 (2) 9914 2888
Clinical Austria, Bio-Rad Laboratories Ges.m.b.H., Hummelgasse 88/3-6, A-1130 Vienna • Phone +43 (0) 1 877 89 01 9 • Fax +43 (0) 1 876-56 29
Belgium, Bio-Rad Laboratories N.V., Winninglaan 3, BE-9140 Temse • Phone +32 (0) 3 710 53 00 • Fax +32 (0) 3 710 53 01
Diagnostics Group Brazil, Bio-Rad Laboratórios Brasil Ltda, Avenida Doutor Chucri Zaidan, 1.240 cj 1902 e 1904 Morumbi Corporate Santo Amaro, São Paulo, SP CEP 04711-130 • Phone +55 11 3065 7550
Canada, Bio-Rad Laboratories Ltd., 2403 Guénette Street, Montréal, Québec H4R 2E9 • Phone +1 514 334 4372 • Fax +1 514 334 0872
China, Bio-Rad Laboratories (Shanghai) Co., Ltd. Room 601, Allian Plaza, No. 168 Jingzhou Road, Yangpu District, Shanghai 200082 • Phone +86 21 6169 8500 • Fax +86 21 6169 8599
9500 Jeronimo Road Czech Republic, Bio-Rad spol. s r.o., Pikrtova 1737/1a, 14000 Prague 4 • Phone +420 241 431 660
Irvine, California 92618 Denmark, Bio-Rad Laboratories, Symbion Science Park, Fruebjergvej 3, DK-2100 Copenhagen East • Phone +45 44 52 10 00 • Fax +45 44 52 10 01
(800) 854-6737 Finland, Bio-Rad Finland Oy, Kutomotie 16 FI-00380, Helsinki • Phone +358 9 804 22 00
France, Bio-Rad, 3 boulevard Raymond Poincaré, 92430 Marnes-la-Coquette • Phone +33 (0)1 47 95 60 00 • Fax +33 (0)1 47 41 91 33
FAX (949) 598-1550 Germany, Bio-Rad Laboratories GmbH, Kapellenstraße 12, D-85622 Feldkirchen, Munich • Phone +49 (0) 89 31884 393 • Fax +49 (0) 89 31884 136
bio-rad.com/qualitycontrol Greece, Bio-Rad Laboratories M E.P.E, 2-4 Mesogion Ave. (Athens Tower) 11527 Ampelokipi, Athens • Phone +30 210 7774396 • Fax +30 210 7774376
Hong Kong, Bio-Rad Pacific Ltd., Unit 1101, 11/F DCH Commercial Centre, 25 Westlands Road, Quarry Bay • Phone +85 2 2789 3300 • Fax +85 2 2789 1257
Hungary, Bio-Rad Hungary Ltd., Futó utca 47-53, 1082, Budapest • Phone +36 1 459 6190 • Fax +36 1 459 6101
Technical Service: India, Bio-Rad Laboratories India Pvt. Ltd., EMAAR Digital Greens, 9th Floor, Tower A- Sector 61 Gurugram-122 102, Haryana 122 015 • Phone +91 124 4029300 • Fax +91 124 2398115
Israel, Bio-Rad Laboratories Ltd., 14 Homa Street, New Industrial Area, Rishon Le Zion 75150 • Phone +972 3 963 6025 • Fax +972 3 951 4129
(800) 854-6737
Italy, Bio-Rad Laboratories S.r.l., Via Cellini 18/A, 20090 Segrate, Milan • Phone +39 024 94 86 600 • Fax +39 02 21609399
Japan, Bio-Rad Laboratories K.K., Tennoz Central Tower 20F, 2-2-24 Higashi-Shinagawa, Shinagawa-ku, Tokyo 140-0002 • Phone +81 3 6361 7070 • Fax +81 3 5463 8481
Korea, Bio-Rad Korea Ltd., 10th Floor, Hyunjuk Building, 832-41, Yeoksam-dong, Gangnam-gu, Seoul 135-080 • Phone +82 080 007 7373 • Fax +82 (2) 3472 7003
Mexico, Bio-Rad, S.A., Avenida Eugenia 197, Piso 10-A, Colonia Narvarte, Delegación Benito Juárez C.P. 03020 Mexico, D.F. • Phone +52 (55) 5488 7670 • Fax +52 (55) 1107 7246
The Netherlands, Bio-Rad Laboratories B.V., Postbus 222, 3900 AE Veenendaal • Phone +31 (0)318 540 666 • Fax +31 (0)318 542 216
New Zealand, Bio-Rad New Zealand, 189 Bush Road Rosedale, Auckland • Phone +64 (9)415 2280 • Fax +64 (9)415 2284
Norway, Bio-Rad Laboratories, Nydalsveien 33, 0484 Oslo • Phone +47 23 38 41 30 • Fax +47 23 38 41 39
Poland, Bio-Rad Polska Sp. z o.o., Przyokopowa 33, Level 4, Building A, 01-208, Warsaw • Phone +48 22 331 99 99 • Fax +48 22 331 99 88
Portugal, Bio-Rad Laboratories, Lda., Edificio Prime, Ave. Quinta Grande, 53 - Fracção 3B Alfragide 26114-521, Amadora • Phone +351 21 47 27 700 • Fax +351 21 47 27 777
Russia, Bio-Rad Laboratorii, 117105, Russian Federation, Moscow, Varshavskoe sh., 9, Bldg., 1B • Phone +7 495 721 1404 • Fax +7 495 721 1412
Singapore, Bio-Rad Laboratories (Singapore) Pte. Ltd., 3A International Business Park Road, #11-10/16, ICON @ IBP Tower B, Singapore 609935 • Phone +65 6415 3170 • Fax +65 6415 3189
South Africa, Bio-Rad Laboratories (Pty) Ltd., 34 Bolton Ave., Rosebank, Johannesburg • Phone +27 11 442 8508 • Fax +27 11 442 8525
Spain, Bio-Rad Laboratories, S.A., C/ Caléndula, 95, Edificio M. Miniparc II, El Soto de la Moraleja, 28109 Alcobendas • Phone +34 91 490 6580 • Fax +34 91 590 5211
Sweden, Bio-Rad Laboratories A.B., Solna Strandväg 3, SE-171 54 Solna, P.O. Box 1097, SE-172 22 Sundyberg • Phone +46 844 98053 • Fax +46 8 55 51 27 80
Switzerland, Bio-Rad Laboratories AG, Pra Rond 23, CH-1785 Cressier • Phone +41 (0) 61 717 9555 • Fax +41 (0) 61 717 9550
Taiwan, Bio-Rad Laboratories Taiwan Ltd., 14th F B, No. 126, Sec. 4, Nan-King East Road, Taipei 10546 Taiwan, R.O.C. • Phone +886 (2) 2578-7189 • Fax +886 (2) 2578-6890
Thailand, Bio-Rad Laboratories Ltd., 1st & 2nd Floor, Lumpini I Bldg., 239/2 Rajdamri Rd., Lumpini, Pathumwan, Bangkok 10330 • Phone (662) 651 8311 • Fax (662) 651 8312
United Kingdom, Bio-Rad Laboratories Ltd., The Junction Station Road, Watford, Hertfordshire, WD17 1ET • Phone +44 (0)1923 471301 • Fax +44 (0)1923 471340 04/20

© 2021 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2021-04 • 5354-00