Immulite 2500 Vitamin B12 Model L5KVB2-200 Test, L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test, L5KFO6-6

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K060929 ↗

FDA Product Code

CDD

Models / Variants

L5KVB2-200 Test

L5KVB6-600 Test

Immulite 2500 Folic Acid Model L5KFO2-200 Test

L5KFO6-6

Device Class

Class II

Regulation

21 CFR Part 862.1810

Advisory Committee

Clinical Chemistry

FDA Decision

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See all devices from Diagnostic Products Corp. →

• What is the Immulite 2500 Vitamin B12/Folic Acid Test used for?

  The Immulite 2500 Vitamin B12 and Folic Acid Tests are designed as solid-phase, two-site chemiluminescent enzyme immunoassays for quantitative measurement of vitamin B12 and folic acid levels in patient samples. These tests aid clinicians in diagnosing and monitoring deficiencies or related conditions, such as megaloblastic anemia or neurological disorders linked to low vitamin B12 or folic acid. They are intended for use exclusively in clinical laboratory settings by trained personnel.

• Which sample types can be tested with the Immulite 2500 Vitamin B12/Folic Acid Tests?

  The Immulite 2500 Vitamin B12 and Folic Acid Tests are compatible with serum, plasma, and whole blood samples. The analyzer processes these samples automatically, ensuring accurate and reliable results for clinical decision-making. The tests are not designed for other sample types, such as urine or cerebrospinal fluid.

• Are the Immulite 2500 Vitamin B12/Folic Acid Tests single-use or reusable?

  The Immulite 2500 Vitamin B12 and Folic Acid Tests are supplied as single-use reagents. This design ensures consistency in test performance and reduces the risk of cross-contamination between samples. Single-use reagents are also aligned with standard in vitro diagnostic protocols for safety and regulatory compliance.

• What models are available for the Immulite 2500 Vitamin B12 and Folic Acid Tests?

  The Immulite 2500 Vitamin B12 Tests come in two models: L5KVB2-200 and L5KVB6-600, indicating different reagent pack sizes (200 and 600 tests, respectively). Similarly, the Folic Acid Tests are available as L5KFO2-200 and L5KFO6-600, following the same pack size structure. The model number helps laboratories select the appropriate quantity for their workflow and sample volume.

• How should the Immulite 2500 Vitamin B12/Folic Acid Tests be stored?

  The Immulite 2500 Vitamin B12 and Folic Acid Tests must be stored according to standard in vitro diagnostic protocols to maintain their integrity and performance. Typically, this involves refrigeration at 2–8°C (36–46°F) and protection from light until use. Always refer to the manufacturer’s instructions for precise storage guidelines, including expiration dates and handling precautions to prevent degradation.