CENMED 18000698
GUDID 00810042682962
CenMed hCG Serum Control POSITIVE, 5mL
BIOCHEMICAL DIAGNOSTICS INC
Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control| Primary Device ID | 00810042682962 |
| NIH Device Record Key | 7a4b060f-628b-4180-a862-34afb33bddc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CENMED |
| Version Model Number | 2122015 |
| Catalog Number | 18000698 |
| Company DUNS | 028007698 |
| Company Name | BIOCHEMICAL DIAGNOSTICS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810042682962 [Primary] |
FDA Product Code
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-08 |
| Device Publish Date | 2021-03-31 |
On-Brand Devices [CENMED]
| 00810042682962 | CenMed hCG Serum Control POSITIVE, 5mL |
| 00810042682948 | CenMed hCG Serum Control NEGATIVE, 5mL |
| 00810042683129 | CenMed hCG URINE Control POSITIVE, 5mL |
| 00810042683112 | CenMed hCG URINE Control NEGATIVE, 5mL |
Trademark Results [CENMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CENMED 86756750 5101540 Live/Registered |
Cen-Med Enterprises, Inc. 2015-09-15 |
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