Device
Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the
Manufacturer
TECHNO-PATH MANUFACTURING LIMITED
TECHNO-PATH MANUFACTURING LIMITED
Model: SR111MU
DI: 05391523442251
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the
heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in their
package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cc226e9b-38a4-4eff-b994-e825365792ab
Distribution Status:
In Commercial Distribution
DUNS Number:
896365983
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05391523442251
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47869
Name: Multiple-type clinical chemistry analyte profile IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
FDA Product Codes
QCH
Assayed Quality Control Material For Clinical Microbiology Assays
Premarket Submissions
Submission Number:
BK251207
Supplement Number:
0