Who else makes this device?

Name: C-Peptide Elisa
Brand: C-Peptide Elisa

Clinical Chemistry › Test SystemsRadioimmunoassay, 17-Hydroxyprogesterone

C-Peptide Elisa

The DRG C-Peptide ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of C-Peptide in serum, plasma (EDTA, lithium heparin or citrate plasma) and urine.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code JLX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84

Record

Regulatory record for C-Peptide Elisa
Listed by	DRG International, Inc., United States
FDA product code	JLX
Device type	Radioimmunoassay, 17-Hydroxyprogesterone
Device class	Class 1
Regulation	21 CFR 862.1395
Establishment	Repacker / relabeller, Complaint-file establishment
Premarket notification	Exempt
Record published	2023-08-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for C-Peptide Elisa
Catalogue number	Size	Status
EIA-1293		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
AutoDELFIA Neonatal 17α-OH-progesterone kit	Wallac OY	3
DBC 17α-Hydroxyprogesterone (17α-OHP) Elisa	Diagnostics Biochem Canada, Inc.	3
17 OH-Progesterone Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Salivary 17-OH Progesterone Elisa	DRG Instruments Gesellschaft mit beschränkter Haftung	2
Progesterone (17-a-OH Progesterone)	DRG Instruments Gesellschaft mit beschränkter Haftung	2
AccuDiag™ 17-alpha-OH Progesterone Elisa	Diagnostic Automation, Inc.	1
GSP Neonatal 17α-OH-progesterone kit	Wallac OY	1
N-17-OHP AccuBind Elisa Test System – 960 Wells	Monobind, Inc.	1
17 OH Progesterone Elisa	DRG International, Inc.	1
N-17-OHP AccuBind Elisa Test System – 96 Wells	Monobind, Inc.	1
Progesterone (17-a-OH Progesterone)	DRG International, Inc.	1
N-17-OHP AccuBind Elisa Test System – 480 Wells	Monobind, Inc.	1

Showing 12 of 35. All products under Radioimmunoassay, 17-Hydroxyprogesterone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K062534	2008-01-29

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2024-09-13	Class III	Process change control	The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may	504 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.