Who else makes this device?

Name: Lactoferrin Elisa
Brand: Lactoferrin Elisa

Immunology & Microbiology › Immunological Test SystemsLactoferrin, Antigen, Antiserum, Control

Lactoferrin Elisa

2 catalogue numbers from K 6870.20.US, listed by Immundiagnostik, Inc., United States, under Lactoferrin, Antigen, Antiserum, Control. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code DEG
Manufacturer	City	Province	Registered as	Device types
AVE Science & Technology Co., Ltd.	Changsha	Hunan	Manufacturer	22

Record

Regulatory record for Lactoferrin Elisa
Listed by	Immundiagnostik, Inc., United States
FDA product code	DEG
Device type	Lactoferrin, Antigen, Antiserum, Control
Device class	Class 1
Regulation	21 CFR 866.5570
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2023-06-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Lactoferrin Elisa
Catalogue number	Size	Status
K 6870.20.US		In distribution
K 6870.US		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Anti-Lactoferrin Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Lactoferrin Chek	Techlab, Inc.	2
Leuko EZ VUE	Techlab, Inc.	2
Lactoferrin EZ VUE	Techlab, Inc.	2
Lactoferrin Scan	Techlab, Inc.	2
Alpco Lactoferrin Clia Kit	American Laboratory Products Company	2
Lactoferrin Clia Re-Calibrator and Control Set	American Laboratory Products Company	1
GeroaDX	Geroa Diagnostics Sociedad Limitada	1
QuickVue TLI Lactoferrin Test	Techlab, Inc.	1

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-03-27	Class II	No Marketing Application	Marketed without a 510k	88 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.