Identity
- Trade Name
- QUANTA Lite® M2 EP (MIT3) ELISA FDA UDI
- Generic Name
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1 M2 EP (MIT3) ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive 4. 1x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 704540 FDA UDI
- Description
- 1. 1 M2 EP (MIT3) ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted M2 EP (MIT3) ELISA Low Positive 4. 1x 1.2mL prediluted M2 EP (MIT3) ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593119 FDA UDI
- 510(k) Number
- K052262 FDA UDI
- FDA Product Code
- DBM FDA UDI
- GMDN Term
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5090 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
QUANTA Lite® M2 EP (MIT3) ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA).
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- DIASTAT anti-Mitochondrial — Euro-Diagnostica AB · Class II
- QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K052262 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 270c358a-cd56-43f4-804a-3c82dfae6899 36 fields · synced Jun 8, 2026