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QUANTA Flash

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 701060Ref 701222Ref 701227Ref 701220Ref 701358Ref 701191Ref 701267Ref 701357Ref 701340Ref 701240Ref 701233Ref 701297Ref 701256Ref 701221Ref 701342Ref 701187

by Inova Diagnostics. Inc.

Identity

Trade Name
QUANTA Flash EUDAMED
QUANTA Flash® ENA7 Calibrators FDA UDI
QUANTA Flash RF IgM Controls FDA UDI
QUANTA Flash® B2GP1 IgA Reagents FDA UDI
QUANTA Flash® aCL IgG Reagents FDA UDI
QUANTA Flash® LKM-1 Controls FDA UDI
QUANTA Flash RF IgM Reagents FDA UDI
QUANTA Flash® aCL IgA Controls FDA UDI
QUANTA Flash® B2GP1-Domain1 Controls FDA UDI
Generic Name
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, calibrator FDA UDI
Rheumatoid factor IVD, control FDA UDI
Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Liver-kidney microsome 1 antibody (anti-LKM1) IVD, control FDA UDI
Rheumatoid factor IVD, kit, chemiluminescent immunoassay FDA UDI
Anticardiolipin antibody IVD, control FDA UDI
Beta-2-glycoprotein I antibody IVD, control FDA UDI
Device Name
QUANTA Flash® aPL Multi Controls EUDAMED
QUANTA Flash® CTD Screen Plus Controls EUDAMED
QUANTA Flash® aCL IgA Controls EUDAMED
QUANTA Flash® CTD Screen Plus Reagents EUDAMED
QUANTA Flash® Intrinsic Factor Reagents EUDAMED
QUANTA Flash® Ribosomal P Calibrators EUDAMED
QUANTA Flash® DFS70 Controls EUDAMED
QUANTA Flash® Intrinsic Factor Controls EUDAMED
QUANTA Flash® RF IgM Reagents EUDAMED
QUANTA Flash® B2GP1 IgA Reagents EUDAMED
QUANTA Flash® aCL IgG Reagents EUDAMED
QUANTA Flash® LKM-1 Controls EUDAMED
QUANTA Flash® ENA7 Calibrators EUDAMED
QUANTA Flash® CTD Screen Plus Calibrators EUDAMED
QUANTA Flash® RF IgM Controls EUDAMED
QUANTA Flash® B2GP1-Domain1 Controls EUDAMED
1. QUANTA Flash ENA7 Calibrator 1: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash ENA7 Calibrator 2: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives." FDA UDI
1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. 2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. FDA UDI
1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 FDA UDI
1. 1 QUANTA Flash aCL IgG Reagent Cartridge 2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 FDA UDI
1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives. 2. QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives." FDA UDI
1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations: a. Rabbit pAb coated paramagnetic beads. b. Assay buffer - colored pink, containing proteing stabilizers and preservatives. c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives. FDA UDI
1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. 2. QUANTA Flash aCL IgA High Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. FDA UDI
1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. FDA UDI
Model / Reference
701060 EUDAMED
701222 EUDAMED
701227 EUDAMEDFDA UDI
701220 EUDAMED
701358 EUDAMED
701191 EUDAMED
701267 EUDAMED
701357 EUDAMED
701256 EUDAMEDFDA UDI
701342 EUDAMEDFDA UDI
701240 EUDAMEDFDA UDI
701233 EUDAMEDFDA UDI
701297 EUDAMEDFDA UDI
701340 EUDAMEDFDA UDI
701187 EUDAMEDFDA UDI
701221 EUDAMED
Description
1. QUANTA Flash ENA7 Calibrator 1: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash ENA7 Calibrator 2: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives." FDA UDI
1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. 2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. FDA UDI
1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 FDA UDI
1. 1 QUANTA Flash aCL IgG Reagent Cartridge 2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 FDA UDI
1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives. 2. QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives." FDA UDI
1. QUANTA Flash RF IgM Reagent Cartridge contains the following reagents for 100 determinations: a. Rabbit pAb coated paramagnetic beads. b. Assay buffer - colored pink, containing proteing stabilizers and preservatives. c. Tracer IgM - Isoluminol labeled anti-human IgM antibody, containing buffer, protein stabilizers and preservatives. FDA UDI
1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. 2. QUANTA Flash aCL IgA High Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. FDA UDI
1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. FDA UDI

Identifiers

Primary DI / UDI-DI
08426951393961 EUDAMED
08426950627814 EUDAMED
08426950597483 EUDAMEDFDA UDI
08426950627791 EUDAMED
08430793039970 EUDAMED
08426950601968 EUDAMED
08426950602002 EUDAMED
08430793039963 EUDAMED
08426950566397 EUDAMEDFDA UDI
08426950845263 EUDAMEDFDA UDI
08426951289257 EUDAMEDFDA UDI
08426950544203 EUDAMEDFDA UDI
08426950766995 EUDAMEDFDA UDI
08426950845249 EUDAMEDFDA UDI
08426950601944 EUDAMEDFDA UDI
08426950627807 EUDAMED
Basic UDI-DI
B-08426951393961 EUDAMED
B-08426950627814 EUDAMED
B-08426950597483 EUDAMED
B-08426950627791 EUDAMED
B-08430793039970 EUDAMED
B-08426950601968 EUDAMED
B-08426950602002 EUDAMED
B-08430793039963 EUDAMED
B-08426950845249 EUDAMED
B-08426951289257 EUDAMED
B-08426950544203 EUDAMED
B-08426950766995 EUDAMED
B-08426950566397 EUDAMED
B-08426950627807 EUDAMED
B-08426950845263 EUDAMED
B-08426950601944 EUDAMED
510(k) Number
K122923 FDA UDI
K120817 FDA UDI
K092181 FDA UDI
K163538 FDA UDI
K190088 FDA UDI
K152875 FDA UDI
FDA Product Code
JIX FDA UDI
JJX FDA UDI
MSV FDA UDI
MID FDA UDI
DHR FDA UDI
EMDN Code
W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
W0102152004 CARDIAC MARKER CONTROLS EUDAMED
W0102100101 ANA SCREENING EUDAMED
W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMED
W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY EUDAMED
W01021110 RHEUMATOID FACTORS EUDAMED
W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
GMDN Term
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, calibrator FDA UDI
Rheumatoid factor IVD, control FDA UDI
Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay FDA UDI
Anticardiolipin antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Liver-kidney microsome 1 antibody (anti-LKM1) IVD, control FDA UDI
Rheumatoid factor IVD, kit, chemiluminescent immunoassay FDA UDI
Anticardiolipin antibody IVD, control FDA UDI
Beta-2-glycoprotein I antibody IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Class I FDA UDI
Regulation Number
862.1150 FDA UDI
862.1660 FDA UDI
866.5660 FDA UDI
866.5775 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMED

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMEDEUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA 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 UDIFDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

QUANTA Flash by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics. Inc.
EUDAMED SRN
US-MF-000017851
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (24)

  • EUDAMED 90721f00-43e8-48ac-899e-066be2082842 61 fields · synced Sep 18, 2026
  • EUDAMED f9a48ad2-3115-4d27-a0f7-c361923724aa 61 fields · synced May 17, 2026
  • EUDAMED 6a8f957b-ed80-4bc6-9971-ec7fa9ae27a9 61 fields · synced May 18, 2026
  • EUDAMED 61fcb011-c518-4fd7-a3d8-7e215302b502 61 fields · synced May 18, 2026
  • EUDAMED 66c3e9f8-2fc4-4d49-82e0-16180cc2d6e0 61 fields · synced May 18, 2026
  • EUDAMED fd85af1e-607c-49f7-8be5-b871efc75b78 61 fields · synced May 18, 2026
  • EUDAMED c009f025-df49-4b06-bfb9-7d9d42789d90 61 fields · synced May 18, 2026
  • EUDAMED fcb3d09f-3c7c-417b-8f9f-57c37a649d8e 61 fields · synced May 18, 2026
  • FDA UDI 3011891b-bbde-4206-a50a-ab0d4a6a51db 36 fields · synced May 27, 2026
  • FDA UDI eb89fb7d-db25-4d36-a15b-8ac29a29b3ef 35 fields · synced May 29, 2026
  • FDA UDI 5fd11fe2-511d-47a6-af31-b7ca15625d8a 36 fields · synced May 30, 2026
  • FDA UDI 177ac7a9-5f5c-4213-b97b-98b01a0b27ff 36 fields · synced May 30, 2026
  • FDA UDI 34938c47-a2f0-4024-a46a-48ae759ba202 36 fields · synced May 30, 2026
  • FDA UDI 7a388e60-7dd7-4165-9124-eb7f69fc977c 36 fields · synced May 30, 2026
  • FDA UDI 1e64c52d-e4c3-42a4-bccc-ca3a76fbdc66 36 fields · synced May 30, 2026
  • FDA UDI 27ffb1d3-3cea-4f0d-89d9-a67959b1ada1 36 fields · synced May 30, 2026
  • EUDAMED e85696c0-31c5-4564-a802-2f1fb5007560 61 fields · synced Jul 9, 2026
  • EUDAMED 22cf6f48-4a0e-4d8f-a318-8a2d5c114c76 61 fields · synced Jul 10, 2026
  • EUDAMED ec6467b7-1022-4f15-a062-202b7c74f4a8 61 fields · synced Jul 17, 2026
  • EUDAMED 3041189a-adfd-4a4f-bcce-91e7a4d0497e 61 fields · synced Jul 19, 2026
  • EUDAMED af947f43-e4f4-462f-bb30-419a7eb2d784 61 fields · synced Jul 23, 2026
  • EUDAMED 162dbdf3-9b27-4c6d-9f6d-2d0778010a99 61 fields · synced Jul 31, 2026
  • EUDAMED a0b1d53d-4d77-4db8-a5d1-ec1e9cfe3a0b 61 fields · synced Aug 2, 2026
  • EUDAMED 64107fe6-a906-409b-90d1-45bb5eb903cb 61 fields · synced Aug 4, 2026