6840 In-body diagnostic reagent classification sub-catalog part of the content adjustment.

On October 22nd, the State Drug Administration issued a notice on the adjustment of the contents of the sub-catalogue of 6840 in-body diagnostic reagents (2013 edition) (No. 112 of 2020).
. The contents of the adjustment are adjusted to the management category and intended use of some in-body diagnostic reagents in the Product Category III-7 reagents related to tumor markers in the Sub-Catalog of 6840 In-body Diagnostic Reagents, as detailed in the annex.
II. Implementation requirements (1) From the date of the issuance of this announcement, the drug regulatory department shall, in accordance with the Measures for the Administration of the Registration of In-body Diagnostic Reagents, the Amendments to the Measures for the Registration and Administration of In-body Diagnostic Reagents, and the Announcement on the Requirements for the Publication of the Registration and Declaration of In-body Diagnostic Reagents and the Approval of the Document Format, accept the registration of in-body diagnostic reagents in accordance with the adjusted categories for review and approval.
(2) For in-body diagnostic reagents that have not yet been approved for registration, the drug regulatory department shall continue to approve the medical device registration in accordance with the original acceptance category, issue the medical device registration certificate, and indicate the adjusted product management category in the registration certificate comments column.
(iii) For registered in-body diagnostic reagents, if the management category is adjusted from high to low, the medical device registration certificate shall remain in effect for the duration of the validity period.
If renewal is required, the registrar shall apply to the corresponding drug regulatory department for renewal of registration in accordance with the changed category six months before the expiration of the validity period of the medical device registration certificate, and if the renewal registration is granted, the medical device registration certificate shall be issued in accordance with the adjusted product management category.
change of registration occurs within the validity period of the medical device registration certificate, the registrar shall apply to the original registration department for a change in registration.
(5) The provincial drug supervision and administration departments shall strengthen the publicity training for the adjustment of the category adjustment of the sub-catalogue of 6840 in vitro diagnostic reagents (2013 edition) and effectively do a good job in the review and approval of relevant products and post-market supervision.
this announcement shall be implemented from the date of publication.
Annex: 6840 in vitro diagnostic reagent classification sub-catalog part content adjustment table serial number catalog serial number product classification name after the content of the expected use management category expected use management category 1171 cancer embryo antigen (CEA) testing reagents used to detect cancer embryo antigen (CEA) in human samples, clinically mainly used for malignant tumor efficacy observation, prognosis and recurrence monitoring.
CLASS III. is used to detect cancer embryo antigens (CEA) and clinically for the observation, prognosis and recurrence monitoring of malignant tumor efficacy.
Class II Class II 2175 cell keratin 19 fragments (CYFRA21-1) testing reagents used to detect cell keratin fragments 19 (CYFRA21-1) in human samples, clinically mainly used for non-small cell lung cancer efficacy observation, recurrence monitoring and so on.
III. Class III is used to detect cell keratin 19 fragments (CYFRA21-1) and is clinically used for efficacy observation and recurrence monitoring of non-small cell lung cancer.
Class II 3176 squamous endocrine cell carcinoma antigen (SCC) testing reagents are used to detect squamous endocrine cell carcinoma antigens in human samples and are clinically used for complementary diagnosis of cervical cancer, non-small cell carcinoma, etc.
III. class is used to detect squamous cortical cell carcinoma antigens (SCC), clinically used for the treatment and monitoring of cervical cancer, non-small cell carcinoma, etc.
Class II Class II 4177 neuron-specific oleolase (NSE) testing reagents are used to detect neuron-specific oleolase in human samples, clinically mainly used for the auxiliary diagnosis of small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) identification diagnosis, monitoring SCLC and neuroblastoma disease changes, treatment response and monitoring recurrence.
III. Class iii is used to detect neuron-specific oleolase (NSE), clinically used in the treatment of lung cancer and neuroblastoma, etc. to monitor and monitor recurrence.
Class II 5178 people with testosterone 4 (HE4) test reagents used to detect testosterone 4 (HE4) antigens in human samples, clinically mainly used for the auxiliary diagnosis of ovarian cancer and efficacy monitoring.
III. Class III is used to detect human testosterone 4 (HE4), clinically used for ovarian cancer efficacy monitoring.
Class II 6179 cancer antigen 125 (CA125) test reagents are used to detect cancer antigen 125 (CA125) in human samples, clinically mainly used for auxiliary diagnosis and treatment monitoring of diseases such as ovarian cancer.
III. Class III is used to detect cancer antigen 125 (CA125) and is clinically used for the treatment and monitoring of diseases such as ovarian cancer.
Class II 7180 cancer antigen 15-3 (CA15-3) test reagents used to detect cancer antigen 15-3 (CA15-3) in human samples, clinically mainly used for breast cancer treatment efficacy and prognosis observation.
III. Class III is used to detect cancer antigen 15-3 (CA15-3) and is clinically used for breast cancer treatment efficacy and prognosis observation.
class II class 8181 sugar antigen 19-9 (CA19-9) test reagents used to detect sugar antigen 19-9 (CA19-9) in human samples, clinically mainly used for the pancreas and other digestive tract malignant tumors auxiliary diagnosis, efficacy monitoring and so on.
CLASS III. Class is used to detect the efficacy of sugar antigen 19-9 (CA19-9) and clinically for the monitoring of the efficacy of malignant tumors in the digestive tract such as the pancreas.
Class II 9182 sugar antigen 242 (CA242) test reagents are used to detect sugar antigens (CA242) in human samples, clinically mainly used for pancreatic cancer, colorectal cancer and other gastrointestinal malignancies auxiliary diagnosis and efficacy monitoring.
Class III. is used to detect sugar antigen 242 (CA242), clinically used for pancreatic cancer, colorectal cancer and other gastrointestinal malignancies efficacy monitoring.
Class II 10183 Sugar Antigen 50 (CA50) test reagents are used to detect sugar antigen 50 (CA50) in human samples, clinically mainly used for digestive tumors (such as pancreatic cancer) of the disease process and efficacy monitoring.
III. Class III is used to detect the progression and efficacy of sugar antigen 50 (CA50), which is clinically used to monitor the progression and efficacy of digestive tumors such as pancreatic cancer.
Class II 11184 cancer antigen 72-4 (CA72-4) test reagents used to detect cancer antigen 724 (CA72-4) in human samples, clinically mainly used for gastrointestinal system and other malignant tumors auxiliary diagnosis and efficacy monitoring.
III. Class III is used to detect cancer antigen 72-4 (CA72-4), clinically used for the monitoring of the efficacy of malignant tumors such as gastrointestinal system.
class II 12185 tissue peptide-specific antigen (TPS) testing reagents are used to detect tissue polypeptide-specific antigens (TPS) in human samples, clinically mainly used for the auxiliary diagnosis of breast, ovaries, digestive system and other tumors and efficacy monitoring.
III. Class III is used to detect tissue peptide-specific antigens (TPS), clinically used for the monitoring of the efficacy of breast, ovaries, digestive system and other tumors.
Class II 13186 beta-2 microglobulin (beta-2 MG) testing reagents are used to detect beta-2 microglobulins in human samples, mainly related to tumors and multiple myeloma.
III. Class III is used to detect beta 2 microglobulin (beta 2 MG), clinically used for the treatment and monitoring of tumors and multiple myeloma.
Class II 14187 ferrrotein testing reagents are used to detect ferroprotein in human samples, and are clinically mainly used for the monitoring of recurrence and metastasis of malignant tumors.
III. Class III is used to detect ferrine, which is clinically used for the monitoring of recurrence and metastasis of malignant tumors.
Class II 15188S100 protein testing reagents are used to detect S100 proteins in human samples and are clinically used for the treatment and monitoring of central nervous system tumors.
III. Class III is used to detect S100 proteins and is clinically used for therapeutic monitoring of tumors in the central nervous system.
class ii 16191 prostate alkaline phosphatase (PAP) testing reagents are used to detect prostate alkaline phosphatase (PAP) in human samples clinically mainly used for the auxiliary diagnosis of prostate cancer, treatment effect and prognosis assessment and metastatic bone tumor identification diagnosis.
III. Class iii is used to detect prostate alkaline phosphatase (PAP), clinically used for the therapeutic effect of prostate cancer and prognostic evaluation and treatment monitoring of metastatic bone tumors.
Class II 17192 prostate acid phosphatase (PACP) testing reagents are used to detect prostate acid phosphatase (PACP) in human samples, clinically mainly used to monitor the occurrence of bone metastasis of prostate cancer.
CLASS III. is used to detect prostate acid phosphatase (PACP), which is clinically used to monitor bone metastasis in prostate cancer.
Class II 18193 thymus nucleoside kinase (TK) testing reagents are used to detect thymus nucleoside kinase (TK) in human samples, clinically mainly used to monitor tumor proliferation and so on.
CLASS III. is used to detect thymus nucleoside kinase (TK), clinically used to monitor tumor proliferation.
Class II 19194 gastric progrogen release peptide prebiotic (proGRP) testing reagents are used to detect gastric progRP in human samples, clinically mainly used for auxiliary diagnosis of small cell lung cancer (SCLC) and so on.
III. Class III is used to detect gastric progenin-releasing peptide prebiobodies (proGRP) and is clinically used for therapeutic monitoring of small cell lung cancer (SCLC).
Class II 20195 Gastroprotease (PG) I test reagents are used to detect gastric proteaseogen (PG)I in human samples.
PGI concentration level and PGI/II. ratio can be used for auxiliary diagnosis of stomach cancer.
III. Class III is used to detect gastric protease (PG)I, clinically used to monitor PGI concentration levels and PGI/II. ratio can be used for the treatment and monitoring of stomach cancer.
Class II 21196 gastric proteaseogen (PG) II. Testing reagents are used to detect gastric proteasegen (PG) II.
the concentration level of PGII.and the ratio of PGI/II. can be used for the auxiliary diagnosis of stomach cancer.
III. Class III. is used to detect gastric proteases (PG) II. Clinically used to monitor concentration levels of PGII and PGI/II. ratios can be used for the treatment and monitoring of stomach cancer.
Class II 22199 light chain testing reagents are used to detect light chains in human samples (e.g. serum and urine) and are clinically used for the auxiliary diagnosis of multiple myeloma.
CLASS III. Class III is used to detect light chains and is clinically used for the monitoring of the treatment of multiple myeloma.
Class II 23200 light chain testing reagents are used to detect radon light chains in human samples (e.g. serum and urine) and are clinically used for the auxiliary diagnosis of multiple myeloma.
III. Class III. is used to detect the light chain of radon and is clinically used for the treatment and monitoring of multiple myeloma.
Class II 24203 insulin-like growth factor-I test reagents are used to detect insulin-like growth factor-I in human samples and are clinically used for complementary diagnosis and treatment guidance for lung cancer.
III. Class III is used to detect insulin-like growth factor-I, which is clinically used primarily for the monitoring and treatment of lung cancer.
Class II 25204a-L-algal glycosidease testing reagents are used to detect α-L-algal glycosidease in human samples and are clinically used primarily for the auxiliary diagnosis of liver cancer.
III. Class III is used to detect a-L-algal glycosidease, clinically used for the treatment and monitoring of liver cancer.
Class II 26205 prolactin testing reagents are used to detect prolactin in human samples and are clinically used for the auxiliary diagnosis of prolactic tumors.
III. Class III is used to detect prolactin, clinically used for the treatment and monitoring of lactoma.
Class II 27206 calcitonin testing reagents are used to detect calcitonin (CT) in human samples and are clinically used for the auxiliary diagnosis of thyroid myelin-like cancer and small cell lung cancer.
III. Class III is used to detect calcitonin, clinically used in the treatment and monitoring of thyroid myelin-like cancer and small cell lung cancer.
Class II 28207 aromatic sulphase testing reagents are used to detect aromatic sulphate enzymes in human samples and are clinically used for the auxiliary diagnosis of breast and colorectal cancer.
III. Class III is used to detect aromatic sulphate enzymes, which are clinically used for the treatment and monitoring of breast and colorectal cancer.
Class II 29217 blood source cell removal reagents are used in-body to remove parts such as red blood cells and white blood cells from the whole blood, thus obtaining non-blood source cells in the blood for a variety of downstream analyses.
such as circulating tumor cell detection, immunocellular chemistry analysis, building genome maps, etc.
blood-based cell sample processing reagents to remove white blood cells from the whole blood by immunological methods.
Class II.